A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Emicizumab in Healthy Chinese Volunteers

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Completed

CT.gov ID

NCT03380780

Collaborator

(none)

Enrollment

Location

Arm

6.2

Actual Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This single-center, open-label study will evaluate the pharmacokinetics, safety, and tolerability of emicizumab following a single subcutaneous (SC) administration to healthy Chinese subjects.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers Hemophilia A	Drug: Emicizumab	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Single-Center, Open-Label, Single Dose Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Emicizumab in Healthy Chinese Volunteers

Actual Study Start Date :

Mar 12, 2018

Actual Primary Completion Date :

Sep 18, 2018

Actual Study Completion Date :

Sep 18, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Emicizumab	Drug: Emicizumab Participants will receive a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab on Day 1. Other Names: RO5534262

Arm

Intervention/Treatment

Experimental: Emicizumab

Drug: Emicizumab

Participants will receive a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab on Day 1.

Other Names:

RO5534262

Outcome Measures

Primary Outcome Measures

Maximum Observed Plasma Concentration (Cmax) of Emicizumab [Predose on Day 1 and postdose on Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113]
Plasma concentrations of emicizumab were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Pharmacokinetics (PK) parameters were estimated using standard non-compartmental methods.
Area Under the Plasma Concentration Versus Time Curve (AUC) Between Time Zero Extrapolated to Infinity (AUC0-inf) of Emicizumab [Predose on Day 1 and postdose on Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113]
Plasma concentrations of emicizumab were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Pharmacokinetics (PK) parameters were estimated using standard non-compartmental methods.

Secondary Outcome Measures

AUC Between Time Zero and the Time of Last Quantifiable Concentration (AUC0-last) of Emicizumab [Predose on Day 1 and postdose on Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113]
Plasma concentrations of emicizumab were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Pharmacokinetics (PK) parameters were estimated using standard non-compartmental methods.
Time to Cmax (Tmax) of Emicizumab [Predose on Day 1 and postdose on Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113]
Plasma concentrations of emicizumab were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Pharmacokinetics (PK) parameters were estimated using standard non-compartmental methods.
Apparent Terminal Half-Life (t1/2) of Emicizumab [Predose on Day 1 and postdose on Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113]
Plasma concentrations of emicizumab were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Pharmacokinetics (PK) parameters were estimated using standard non-compartmental methods.
Apparent Clearance (CL/F) of Emicizumab [Predose on Day 1 and postdose on Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113]
Plasma concentrations of emicizumab were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Pharmacokinetics (PK) parameters were estimated using standard non-compartmental methods.
Apparent Volume of Distribution (Vz/F) of Emicizumab [Predose on Day 1 and postdose on Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113]
Plasma concentrations of emicizumab were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Pharmacokinetics (PK) parameters were estimated using standard non-compartmental methods.
Mean Residence Time (MRT) of Emicizumab [Predose on Day 1 and postdose on Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113]
Plasma concentrations of emicizumab were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Pharmacokinetics (PK) parameters were estimated using standard non-compartmental methods.
Number of Participants With Adverse Events by Highest World Health Organization (WHO) Toxicity Grade [From screening to study completion (20 weeks)]
The WHO Toxicity Grading Scale was used for assessing adverse event severity. Any adverse event not specifically listed in the WHO Toxicity Grading Scale was assessed according to the following levels of severity: Grade 1 is mild; Grade 2 is moderate; Grade 3 is severe; and Grade 4 is life-threatening. Investigator text for adverse events were encoded using the Medical Dictionary for Regulatory Activities (MedDRA) version 21.1. After informed consent had been obtained but prior to initiation of study drug, only serious adverse events (SAEs) caused by a protocol-mandated intervention were to have been reported. After initiation of study drug, all adverse events, regardless of relationship to study drug, were to have been reported until the participant completed his last study visit. After this period, any SAEs believed to be related to prior study drug treatment were to be reported.
Number of Participants Testing Negative or Positive for the Presence of Anti-Drug Antibodies (ADA) Against Emicizumab by Timepoint and for the Overall Study [Predose at Baseline (Day 1) and postdose on Days 57 and 113]
Participants were considered to be 'ADA Negative (Treatment Unaffected)' if baseline and all post-baseline samples were negative, or if they were ADA positive at baseline but did not have any post-baseline samples with a titer that was at least 4-fold greater than the titer of the baseline sample. 'Total ADA Positive' is the sum of all participants who tested positive for ADA in the 2 following categories: 'ADA Positive (Treatment Induced)', those who were ADA negative at baseline and tested positive for ADA following study drug administration; and 'ADA Positive (Treatment Boosted)', those who were pre-dose ADA positive and had post-baseline samples with a titer that was at least 4-fold greater compared to the baseline measurement.
Number of Participants With Laboratory Test Abnormalities [Baseline and Days 2, 4, 8, 11, 15, 29, 43, 57, 71, 85, and 113]
The number of participants with a laboratory abnormality during treatment (numerator) is reported among the 'number analyzed' in the table below (denominator), which represents the number of participants without that abnormality at baseline (last observation prior to initiation of study drug). Note that samples from all participants were analyzed for each laboratory parameter. Values falling above or below the Roche predefined standard reference range were laboratory abnormalities labelled accordingly as 'high' or 'low'. Not every laboratory abnormality qualified as an adverse event; only if it was accompanied by clinical symptoms, resulted in a change in study treatment or in a medical intervention, or was clinically significant in the investigator's judgment. SGOT/AST = serum glutamic-oxaloacetic transaminase/aspartate transaminase; SGPT/ALT = serum glutamic-pyruvic transaminase/alanine transaminase
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Albumin Concentration [Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113]
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase Concentration [Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113]
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Bilirubin Concentration [Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113]
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Fasting Blood Glucose Concentration [Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113]
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Blood Urea Nitrogen Concentration [Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113]
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: C-Reactive Protein Concentration [Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113]
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Chloride Concentration [Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113]
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Cholesterol Concentration [Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113]
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Creatine Kinase Concentration [Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113]
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Creatinine Concentration [Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113]
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Direct Bilirubin Concentration [Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113]
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Gamma Glutamyl Transferase Concentration [Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113]
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Lactate Dehydrogenase Concentration [Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113]
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Potassium Concentration [Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113]
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Total Protein Concentration [Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113]
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: SGOT/AST Concentration [Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113]
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug. SGOT/AST = serum glutamic-oxaloacetic transaminase/aspartate transaminase
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: SGPT/ALT Concentration [Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113]
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug. SGPT/ALT = serum glutamic-pyruvic transaminase/alanine transaminase
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Sodium Concentration [Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113]
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Fasting Triglycerides Concentration [Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113]
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Uric Acid Concentration [Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113]
Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Activated Partial Thromboplastin Time [Baseline and Days 2, 11, 29, 57, and 113]
Blood samples were collected from participants at the indicated timepoints for evaluation of coagulation parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Fibrinogen Concentration [Baseline and Days 2, 11, 29, 57 and 113]
Blood samples were collected from participants at the indicated timepoints for evaluation of coagulation parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Prothrombin Time [Baseline and Days 2, 11, 29, 57 and 113]
Blood samples were collected from participants at the indicated timepoints for evaluation of coagulation parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Prothrombin Time/International Normalized Ratio (INR) [Baseline and Days 2, 11, 29, 57 and 113]
The INR is a standardized measure of the prothrombin time. Blood samples were collected from participants at the indicated timepoints for evaluation of coagulation parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils, Absolute Count [Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113]
Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils, Absolute Count [Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113]
Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Hemoglobin [Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113]
Erythrocyte mean corpuscular hemoglobin (MCH) is a measure of the average amount of hemoglobin per red blood cell. Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Volume [Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113]
Erythrocyte mean corpuscular volume is a measure of the average volume of a red blood cell. Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Hemoglobin Concentration [Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113]
Erythrocyte mean corpuscular hemoglobin concentration (MCHC) is a measure of the average concentration of hemoglobin per red blood cell. Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit (as a Fraction of 1) [Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113]
Hematocrit is a measure of the ratio of red blood cells (RBCs) in the blood by volume. Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hemoglobin Concentration [Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113]
Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes, Absolute Count [Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113]
Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes, Absolute Count [Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113]
Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Total Neutrophils, Absolute Count [Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113]
Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Platelet Count [Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113]
Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count [Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113]
Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count [Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113]
Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Number of Participants by Test Results for Blood in Urine by Timepoint [Baseline and Days 2, 8, 29, 57, 85, and 113]
Urine samples were collected from participants at the indicated timepoints for evaluation of urinalysis parameters. The number of participants with test results for blood in urine of 0 (Absent), +1 (Trace), +2 (Positive), and +3/+4 (Strong Positive) at baseline and each timepoint are reported. Baseline was defined as the participant's last sample prior to initiation of study drug.
Number of Participants by Test Results for Glucose in Urine by Timepoint [Baseline and Days 2, 8, 29, 57, 85, and 113]
Urine samples were collected from participants at the indicated timepoints for evaluation of urinalysis parameters. The number of participants with test results for glucose in urine of 0 (Absent), +1 (Trace), +2 (Positive), and +3/+4 (Strong Positive) at baseline and each timepoint are reported. Baseline was defined as the participant's last sample prior to initiation of study drug.
Number of Participants by Test Results for Protein in Urine by Timepoint [Baseline and Days 2, 8, 29, 57, 85, and 113]
Urine samples were collected from participants at the indicated timepoints for evaluation of urinalysis parameters. The number of participants with test results for protein in urine of 0 (Absent), +1 (Trace), +2 (Positive), and +3/+4 (Strong Positive) at baseline and each timepoint are reported. Baseline was defined as the participant's last sample prior to initiation of study drug.
Change From Baseline in Vital Signs by Timepoint: Diastolic Blood Pressure [Baseline and Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113]
Vital signs were measured prior to blood sampling while the participant was in a supine position after they had been resting for at least 5 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.
Change From Baseline in Vital Signs by Timepoint: Pulse Rate [Baseline and Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113]
Vital signs were measured prior to blood sampling while the participant was in a supine position after they had been resting for at least 5 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.
Change From Baseline in Vital Signs by Timepoint: Respiratory Rate [Baseline and Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113]
Vital signs were measured prior to blood sampling while the participant was in a supine position after they had been resting for at least 5 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.
Change From Baseline in Vital Signs by Timepoint: Systolic Blood Pressure [Baseline and Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113]
Vital signs were measured prior to blood sampling while the participant was in a supine position after they had been resting for at least 5 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.
Change From Baseline in Vital Signs by Timepoint: Temperature (Axillary) [Baseline and Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113]
Vital signs were measured prior to blood sampling while the participant was in a supine position after they had been resting for at least 5 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.
Change From Baseline in Electrocardiogram (ECG) Results by Timepoint: Heart Rate [Baseline and Days 2, 4, 6, 8, 15, 29, 43, 57, 71, 85, and 113]
The 12-lead electrocardiogram (ECG) measurements were collected in triplicate (three consecutive interpretable ECGs within 5 minutes) after the participant had been in a supine position for at least 10 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.
Change From Baseline in ECG Results by Timepoint: PR Duration [Baseline and Days 2, 4, 6, 8, 15, 29, 43, 57, 71, 85, and 113]
The 12-lead electrocardiogram (ECG) measurements were collected in triplicate (three consecutive interpretable ECGs within 5 minutes) after the participant had been in a supine position for at least 10 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.
Change From Baseline in ECG Results by Timepoint: QRS Duration [Baseline and Days 2, 4, 6, 8, 15, 29, 43, 57, 71, 85, and 113]
The 12-lead electrocardiogram (ECG) measurements were collected in triplicate (three consecutive interpretable ECGs within 5 minutes) after the participant had been in a supine position for at least 10 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.
Change From Baseline in ECG Results by Timepoint: QT Duration [Baseline and Days 2, 4, 6, 8, 15, 29, 43, 57, 71, 85, and 113]
The 12-lead electrocardiogram (ECG) measurements were collected in triplicate (three consecutive interpretable ECGs within 5 minutes) after the participant had been in a supine position for at least 10 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.
Change From Baseline in ECG Results by Timepoint: QTcB Duration (Bazett's Correction Formula) [Baseline and Days 2, 4, 6, 8, 15, 29, 43, 57, 71, 85, and 113]
The 12-lead electrocardiogram (ECG) measurements were collected in triplicate (three consecutive interpretable ECGs within 5 minutes) after the participant had been in a supine position for at least 10 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.
Change From Baseline in ECG Results by Timepoint: QTcF Duration (Fridericia's Correction Formula) [Baseline and Days 2, 4, 6, 8, 15, 29, 43, 57, 71, 85, and 113]
The 12-lead electrocardiogram (ECG) measurements were collected in triplicate (three consecutive interpretable ECGs within 5 minutes) after the participant had been in a supine position for at least 10 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.
Change From Baseline in ECG Results by Timepoint: RR Duration [Baseline and Days 2, 4, 6, 8, 15, 29, 43, 57, 71, 85, and 113]
The 12-lead electrocardiogram (ECG) measurements were collected in triplicate (three consecutive interpretable ECGs within 5 minutes) after the participant had been in a supine position for at least 10 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.
Number of Participants With Concomitant Medications [From screening to study completion (20 weeks)]
The original terms recorded by the investigator for concomitant medications were standardized by the sponsor by assigning preferred terms. The duration of treatment with the concomitant medications ranged from 1 day to 5 days. Except for 1 participant who was treated during the in-clinic period (Days -1 to 4), all other concomitant medications were recorded during the ambulatory period (Days 6 to 113).

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy Chinese male subjects, aged 20-45 years inclusive at the time of screening
Chinese subjects must have Chinese parents and grandparents, all of whom were born in China
A body mass index (BMI) between 19 and 24 kilograms per height in meters squared (kg/m^2), inclusive
Able to participate and willing to give written informed consent and to comply with the study requirements

Exclusion Criteria:

Any history or presence of a clinically significant disorder, or any other condition or disease which in the judgement of the investigator would place the subject at undue risk; interfere with absorption, distribution, metabolism, and excretion of emicizumab; or interfere with the ability of the subject to complete the study
Major illness within 1 month prior to dosing, and/or any condition which could relapse during or immediately after the study
Use of any prescribed or over-the-counter (OTC) medication or herbal medicine taken within 14 days prior to dosing or within 5 times the elimination half-life of the medication prior to dosing (whichever is longer), with some exceptions
Any significant donation/loss of blood or plasma (greater than 450 milliliters) within the 3 months prior to dosing
Regular smoker with consumption of more than 10 cigarettes per day or the equivalent amount of tobacco
Participation within a clinical study with an investigational drug or device within the last 3 months prior to dosing
Any clinically relevant history of hypersensitivity or allergic reactions, either spontaneous or following drug administration or exposure to foods or environmental agents
Previous or concomitant thromboembolic disease such as deep vein thrombosis (DVT) or signs of thromboembolic disease, or family history of thromboembolic disorder such as serious DVT
At high risk for thrombotic microangiopathy (e.g., have a previous medical or family history of thrombotic microangiopathy), in the investigator's judgment
Previous or concomitant autoimmune or connective tissue disease
History of tuberculosis or active tuberculosis with positive test result at screening
Any other reason that, in the judgment of the investigator, would render the subject unsuitable for study participation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University Third Hospital	Beijing		China	100083

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

Study Protocol and Statistical Analysis Plan - Jan 25, 2018

More Information

Publications

None provided.

Responsible Party:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT03380780

Other Study ID Numbers:

YP39308

First Posted:

Dec 21, 2017

Last Update Posted:

Sep 30, 2019

Last Verified:

Sep 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hemophilia A

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Period Title: Overall Study
STARTED	16
COMPLETED	16
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Overall Participants	16
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.6 (6.7)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	16 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	16 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	16 100%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	0 0%
More than one race	0 0%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

Title	Maximum Observed Plasma Concentration (Cmax) of Emicizumab
Description	Plasma concentrations of emicizumab were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Pharmacokinetics (PK) parameters were estimated using standard non-compartmental methods.
Time Frame	Predose on Day 1 and postdose on Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The pharmacokinetics (PK) analysis population included all enrolled participants; participants were planned to be excluded if they deviated significantly from the protocol or if data was unavailable or incomplete which may influence the PK analysis.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Mean (Standard Deviation) [microgram per milliliter (μg/mL)]	7.11 (1.77)

2. Primary Outcome

Title	Area Under the Plasma Concentration Versus Time Curve (AUC) Between Time Zero Extrapolated to Infinity (AUC0-inf) of Emicizumab
Description	Plasma concentrations of emicizumab were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Pharmacokinetics (PK) parameters were estimated using standard non-compartmental methods.
Time Frame	Predose on Day 1 and postdose on Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The pharmacokinetics (PK) analysis population included all enrolled participants; participants were planned to be excluded if they deviated significantly from the protocol or if data was unavailable or incomplete which may influence the PK analysis.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Mean (Standard Deviation) [μg*day/mL]	287 (74.2)

3. Secondary Outcome

Title	AUC Between Time Zero and the Time of Last Quantifiable Concentration (AUC0-last) of Emicizumab
Description	Plasma concentrations of emicizumab were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Pharmacokinetics (PK) parameters were estimated using standard non-compartmental methods.
Time Frame	Predose on Day 1 and postdose on Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The pharmacokinetics (PK) analysis population included all enrolled participants; participants were planned to be excluded if they deviated significantly from the protocol or if data was unavailable or incomplete which may influence the PK analysis.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Mean (Standard Deviation) [μg*day/mL]	268 (63.7)

4. Secondary Outcome

Title	Time to Cmax (Tmax) of Emicizumab
Description	Plasma concentrations of emicizumab were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Pharmacokinetics (PK) parameters were estimated using standard non-compartmental methods.
Time Frame	Predose on Day 1 and postdose on Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The pharmacokinetics (PK) analysis population included all enrolled participants; participants were planned to be excluded if they deviated significantly from the protocol or if data was unavailable or incomplete which may influence the PK analysis.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Median (Full Range) [day]	7.0

5. Secondary Outcome

Title	Apparent Terminal Half-Life (t1/2) of Emicizumab
Description	Plasma concentrations of emicizumab were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Pharmacokinetics (PK) parameters were estimated using standard non-compartmental methods.
Time Frame	Predose on Day 1 and postdose on Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The pharmacokinetics (PK) analysis population included all enrolled participants; participants were planned to be excluded if they deviated significantly from the protocol or if data was unavailable or incomplete which may influence the PK analysis.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Mean (Standard Deviation) [day]	26.7 (4.25)

6. Secondary Outcome

Title	Apparent Clearance (CL/F) of Emicizumab
Description	Plasma concentrations of emicizumab were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Pharmacokinetics (PK) parameters were estimated using standard non-compartmental methods.
Time Frame	Predose on Day 1 and postdose on Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The pharmacokinetics (PK) analysis population included all enrolled participants; participants were planned to be excluded if they deviated significantly from the protocol or if data was unavailable or incomplete which may influence the PK analysis.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Mean (Standard Deviation) [milliliter per day (mL/day)]	235 (88)

7. Secondary Outcome

Title	Apparent Volume of Distribution (Vz/F) of Emicizumab
Description	Plasma concentrations of emicizumab were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Pharmacokinetics (PK) parameters were estimated using standard non-compartmental methods.
Time Frame	Predose on Day 1 and postdose on Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The pharmacokinetics (PK) analysis population included all enrolled participants; participants were planned to be excluded if they deviated significantly from the protocol or if data was unavailable or incomplete which may influence the PK analysis.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Mean (Standard Deviation) [mL]	8870 (2950)

8. Secondary Outcome

Title	Mean Residence Time (MRT) of Emicizumab
Description	Plasma concentrations of emicizumab were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Pharmacokinetics (PK) parameters were estimated using standard non-compartmental methods.
Time Frame	Predose on Day 1 and postdose on Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The pharmacokinetics (PK) analysis population included all enrolled participants; participants were planned to be excluded if they deviated significantly from the protocol or if data was unavailable or incomplete which may influence the PK analysis.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Mean (Standard Deviation) [day]	40.26 (6.34)

9. Secondary Outcome

Title	Number of Participants With Adverse Events by Highest World Health Organization (WHO) Toxicity Grade
Description	The WHO Toxicity Grading Scale was used for assessing adverse event severity. Any adverse event not specifically listed in the WHO Toxicity Grading Scale was assessed according to the following levels of severity: Grade 1 is mild; Grade 2 is moderate; Grade 3 is severe; and Grade 4 is life-threatening. Investigator text for adverse events were encoded using the Medical Dictionary for Regulatory Activities (MedDRA) version 21.1. After informed consent had been obtained but prior to initiation of study drug, only serious adverse events (SAEs) caused by a protocol-mandated intervention were to have been reported. After initiation of study drug, all adverse events, regardless of relationship to study drug, were to have been reported until the participant completed his last study visit. After this period, any SAEs believed to be related to prior study drug treatment were to be reported.
Time Frame	From screening to study completion (20 weeks)

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Any Adverse Event - Any Grade	14 87.5%
Any Adverse Event - Grade 1	7 43.8%
Any Adverse Event - Grade 2	7 43.8%
Any Adverse Event - Grade 3	0 0%
Any Adverse Event - Grade 4	0 0%
Leukopenia - Grade 1	1 6.3%
Diarrhoea - Grade 1	1 6.3%
Flatulence - Grade 1	1 6.3%
Mouth ulceration - Grade 2	1 6.3%
Toothache - Grade 1	1 6.3%
Conjunctivitis - Grade 2	1 6.3%
Gastroenteritis - Grade 2	1 6.3%
Pericoronitis - Grade 1	1 6.3%
Upper respiratory tract infection - Grade 1	3 18.8%
Upper respiratory tract infection - Grade 2	1 6.3%
Injury - Grade 2	1 6.3%
Road traffic accident - Grade 2	1 6.3%
Blood bilirubin increased - Grade 1	1 6.3%
Blood creatinine phosphokinase increased - Grade 1	4 25%
Blood triglycerides increased - Grade 1	1 6.3%
Blood uric acid increased - Grade 1	1 6.3%
C-reactive protein increased - Grade 1	2 12.5%
White blood cell count decreased - Grade 1	1 6.3%
White blood cell count increased - Grade 1	1 6.3%
Hypertriglyceridaemia - Grade 1	1 6.3%
Hypokalaemia - Grade 2	1 6.3%
Cough - Grade 1	1 6.3%
Dry throat - Grade 1	1 6.3%
Nasal congestion - Grade 1	1 6.3%
Nasal obstruction - Grade 2	1 6.3%
Oropharyngeal pain - Grade 1	3 18.8%
Rash - Grade 1	1 6.3%

10. Secondary Outcome

Title	Number of Participants Testing Negative or Positive for the Presence of Anti-Drug Antibodies (ADA) Against Emicizumab by Timepoint and for the Overall Study
Description	Participants were considered to be 'ADA Negative (Treatment Unaffected)' if baseline and all post-baseline samples were negative, or if they were ADA positive at baseline but did not have any post-baseline samples with a titer that was at least 4-fold greater than the titer of the baseline sample. 'Total ADA Positive' is the sum of all participants who tested positive for ADA in the 2 following categories: 'ADA Positive (Treatment Induced)', those who were ADA negative at baseline and tested positive for ADA following study drug administration; and 'ADA Positive (Treatment Boosted)', those who were pre-dose ADA positive and had post-baseline samples with a titer that was at least 4-fold greater compared to the baseline measurement.
Time Frame	Predose at Baseline (Day 1) and postdose on Days 57 and 113

Outcome Measure Data

Analysis Population Description
Includes participants with at least one predose and one postdose anti-drug antibody (ADA) assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline - ADA Positive	0 0%
Baseline - ADA Negative	16 100%
Day 57 - ADA Positive	0 0%
Day 57 - ADA Negative	16 100%
Day 113 - ADA Positive	1 6.3%
Day 113 - ADA Negative	15 93.8%
Overall - ADA Negative (Treatment Unaffected)	15 93.8%
Overall - Total ADA Positive (Induced + Boosted)	1 6.3%
Overall - ADA Positive (Treatment Induced)	1 6.3%
Overall - ADA Positive (Treatment Boosted)	0 0%

11. Secondary Outcome

Title	Number of Participants With Laboratory Test Abnormalities
Description	The number of participants with a laboratory abnormality during treatment (numerator) is reported among the 'number analyzed' in the table below (denominator), which represents the number of participants without that abnormality at baseline (last observation prior to initiation of study drug). Note that samples from all participants were analyzed for each laboratory parameter. Values falling above or below the Roche predefined standard reference range were laboratory abnormalities labelled accordingly as 'high' or 'low'. Not every laboratory abnormality qualified as an adverse event; only if it was accompanied by clinical symptoms, resulted in a change in study treatment or in a medical intervention, or was clinically significant in the investigator's judgment. SGOT/AST = serum glutamic-oxaloacetic transaminase/aspartate transaminase; SGPT/ALT = serum glutamic-pyruvic transaminase/alanine transaminase
Time Frame	Baseline and Days 2, 4, 8, 11, 15, 29, 43, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
Safety analysis population. The number analyzed in the table below represents the number of participants without the specified laboratory abnormality at baseline. Samples from all participants were analyzed for each laboratory parameter.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Albumin - Low	1 6.3%
Alkaline Phosphatase - High	2 12.5%
SGPT/ALT - Low	2 12.5%
SGOT/AST - Low	5 31.3%
Blood Urea Nitrogen - Low	1 6.3%
Blood Urea Nitrogen - High	1 6.3%
Chloride - Low	2 12.5%
Cholesterol - Low	5 31.3%
Cholesterol - High	1 6.3%
Creatine Kinase - High	3 18.8%
C-Reactive Protein - High	6 37.5%
Lactate Dehydrogenase - Low	2 12.5%
Potassium - Low	1 6.3%
Sodium - Low	6 37.5%
Bilirubin - High	2 12.5%
Protein, Total - Low	3 18.8%
Triglycerides (Fasting) - High	6 37.5%
Uric Acid - Low	2 12.5%
Uric Acid - High	4 25%
Fibrinogen - Low	2 12.5%
Activated Partial Thromboplastin Time - Low	13 81.3%
Basophils, Absolute Count - High	4 25%
Eosinophils, Absolute Count - Low	1 6.3%
Eosinophils, Absolute Count - High	2 12.5%
Hematocrit - Low	3 18.8%
Hemoglobin - High	1 6.3%
Lymphocytes, Absolute Count - Low	4 25%
Lymphocytes, Absolute Count - High	1 6.3%
Erythrocyte Mean Corpuscular Hemoglobin (HGB)-High	1 6.3%
Erythro. Mean Corpuscular HGB Concentration - High	8 50%
Monocytes, Absolute Count - High	2 12.5%
Neutrophils, Total, Absolute Count - Low	2 12.5%
Neutrophils, Total, Absolute Count - High	2 12.5%
Platelet - High	1 6.3%
Red Blood Cell Count - Low	3 18.8%
White Blood Cell Count - Low	2 12.5%
Urine pH - High	9 56.3%
Urine Specific Gravity - Low	6 37.5%
Urine Specific Gravity - High	9 56.3%

12. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Albumin Concentration
Description	Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Time Frame	Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	45.43 (1.834)
Change From BL at Day 2	-0.43 (2.391)
Change From BL at Day 4	1.03 (2.016)
Change From BL at Day 8	0.29 (2.095)
Change From BL at Day 15	0.08 (1.928)
Change From BL at Day 29	-0.18 (1.602)
Change From BL at Day 43	-0.41 (1.242)
Change From BL at Day 57	-1.24 (2.298)
Change From BL at Day 71	-0.58 (1.983)
Change From BL at Day 85	-1.56 (2.308)
Change From BL at Day 113	-0.26 (1.732)
Post-BL Minimum Change From BL	-2.87 (1.967)
Post-BL Maximum Change From BL	1.98 (1.521)

13. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase Concentration
Description	Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Time Frame	Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	85.38 (19.500)
Change From BL at Day 2	0.50 (6.792)
Change From BL at Day 4	2.50 (6.542)
Change From BL at Day 8	1.06 (5.813)
Change From BL at Day 15	2.38 (9.150)
Change From BL at Day 29	1.44 (8.959)
Change From BL at Day 43	0.56 (8.756)
Change From BL at Day 57	-3.69 (9.918)
Change From BL at Day 71	-0.94 (11.198)
Change From BL at Day 85	-4.50 (7.589)
Change From BL at Day 113	-0.38 (11.684)
Post-BL Minimum Change From BL	-9.81 (7.556)
Post-BL Maximum Change From BL	9.94 (7.398)

14. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Bilirubin Concentration
Description	Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Time Frame	Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	13.83 (7.556)
Change From BL at Day 2	0.82 (2.921)
Change From BL at Day 4	-0.42 (4.470)
Change From BL at Day 8	-1.10 (3.713)
Change From BL at Day 15	-0.61 (5.909)
Change From BL at Day 29	-0.56 (4.688)
Change From BL at Day 43	-0.25 (3.709)
Change From BL at Day 57	-0.96 (4.034)
Change From BL at Day 71	1.67 (7.467)
Change From BL at Day 85	0.54 (3.861)
Change From BL at Day 113	-0.12 (5.570)
Post-BL Minimum Change From BL	-3.94 (4.749)
Post-BL Maximum Change From BL	5.54 (5.909)

15. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Fasting Blood Glucose Concentration
Description	Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Time Frame	Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	5.03 (0.425)
Change From BL at Day 2	-0.33 (0.384)
Change From BL at Day 4	-0.22 (0.500)
Change From BL at Day 8	-0.16 (0.441)
Change From BL at Day 15	-0.27 (0.382)
Change From BL at Day 29	-0.08 (0.364)
Change From BL at Day 43	-0.08 (0.435)
Change From BL at Day 57	-0.22 (0.515)
Change From BL at Day 71	-0.20 (0.322)
Change From BL at Day 85	-0.25 (0.346)
Change From BL at Day 113	-0.21 (0.470)
Post-BL Minimum Change From BL	-0.64 (0.388)
Post-BL Maximum Change From BL	0.24 (0.386)

16. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Blood Urea Nitrogen Concentration
Description	Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Time Frame	Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	4.46 (0.848)
Change From BL at Day 2	-0.58 (0.877)
Change From BL at Day 4	-0.73 (0.649)
Change From BL at Day 8	0.26 (1.074)
Change From BL at Day 15	0.43 (1.543)
Change From BL at Day 29	0.43 (1.071)
Change From BL at Day 43	0.38 (0.959)
Change From BL at Day 57	0.39 (0.874)
Change From BL at Day 71	0.36 (0.958)
Change From BL at Day 85	0.16 (0.888)
Change From BL at Day 113	0.13 (0.573)
Post-BL Minimum Change From BL	-1.07 (0.587)
Post-BL Maximum Change From BL	1.42 (0.970)

17. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: C-Reactive Protein Concentration
Description	Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Time Frame	Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	0.50 (0.568)
Change From BL at Day 2	0.23 (0.456)
Change From BL at Day 4	0.11 (0.477)
Change From BL at Day 8	0.54 (1.721)
Change From BL at Day 15	0.75 (1.197)
Change From BL at Day 29	1.01 (1.289)
Change From BL at Day 43	0.60 (1.849)
Change From BL at Day 57	0.27 (0.827)
Change From BL at Day 71	0.13 (0.410)
Change From BL at Day 85	0.12 (0.595)
Change From BL at Day 113	1.24 (3.517)
Post-BL Minimum Change From BL	-0.20 (0.397)
Post-BL Maximum Change From BL	3.14 (3.641)

18. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Chloride Concentration
Description	Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Time Frame	Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	104.69 (1.957)
Change From BL at Day 2	-0.69 (2.549)
Change From BL at Day 4	-0.63 (2.363)
Change From BL at Day 8	0.13 (2.579)
Change From BL at Day 15	0.06 (2.175)
Change From BL at Day 29	-1.56 (2.279)
Change From BL at Day 43	-0.06 (1.731)
Change From BL at Day 57	0.75 (2.769)
Change From BL at Day 71	-0.50 (2.757)
Change From BL at Day 85	0.13 (2.630)
Change From BL at Day 113	-0.13 (2.217)
Post-BL Minimum Change From BL	-2.94 (2.016)
Post-BL Maximum Change From BL	2.31 (2.120)

19. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Cholesterol Concentration
Description	Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Time Frame	Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	3.88 (1.103)
Change From BL at Day 2	0.02 (0.393)
Change From BL at Day 4	0.07 (0.439)
Change From BL at Day 8	-0.03 (0.383)
Change From BL at Day 15	-0.04 (0.451)
Change From BL at Day 29	0.03 (0.372)
Change From BL at Day 43	-0.06 (0.441)
Change From BL at Day 57	-0.04 (0.459)
Change From BL at Day 71	-0.01 (0.466)
Change From BL at Day 85	-0.13 (0.515)
Change From BL at Day 113	0.01 (0.394)
Post-BL Minimum Change From BL	-0.47 (0.468)
Post-BL Maximum Change From BL	0.47 (0.222)

20. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Creatine Kinase Concentration
Description	Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Time Frame	Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	121.63 (81.915)
Change From BL at Day 2	-41.13 (54.760)
Change From BL at Day 4	-25.81 (107.494)
Change From BL at Day 8	-22.19 (54.034)
Change From BL at Day 15	-0.94 (39.834)
Change From BL at Day 29	8.50 (122.645)
Change From BL at Day 43	-21.00 (53.551)
Change From BL at Day 57	8.00 (152.217)
Change From BL at Day 71	-19.63 (51.798)
Change From BL at Day 85	-20.00 (77.283)
Change From BL at Day 113	-18.81 (71.191)
Post-BL Minimum Change From BL	-52.38 (72.902)
Post-BL Maximum Change From BL	92.50 (155.002)

21. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Creatinine Concentration
Description	Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Time Frame	Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	83.19 (7.195)
Change From BL at Day 2	-0.56 (7.071)
Change From BL at Day 4	-0.31 (5.147)
Change From BL at Day 8	-1.25 (4.919)
Change From BL at Day 15	-2.00 (9.452)
Change From BL at Day 29	-3.69 (4.672)
Change From BL at Day 43	-2.06 (5.434)
Change From BL at Day 57	-2.38 (5.488)
Change From BL at Day 71	-1.06 (7.344)
Change From BL at Day 85	-1.50 (4.662)
Change From BL at Day 113	-0.19 (6.327)
Post-BL Minimum Change From BL	-9.25 (5.170)
Post-BL Maximum Change From BL	6.13 (6.109)

22. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Direct Bilirubin Concentration
Description	Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Time Frame	Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	1.63 (0.567)
Change From BL at Day 2	0.56 (0.395)
Change From BL at Day 4	0.29 (0.452)
Change From BL at Day 8	0.00 (0.327)
Change From BL at Day 15	-0.07 (0.521)
Change From BL at Day 29	0.12 (0.548)
Change From BL at Day 43	0.12 (0.308)
Change From BL at Day 57	-0.03 (0.342)
Change From BL at Day 71	0.23 (0.509)
Change From BL at Day 85	0.17 (0.515)
Change From BL at Day 113	0.07 (0.480)
Post-BL Minimum Change From BL	-0.39 (0.396)
Post-BL Maximum Change From BL	0.78 (0.448)

23. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Gamma Glutamyl Transferase Concentration
Description	Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Time Frame	Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	19.94 (10.951)
Change From BL at Day 2	-0.50 (1.862)
Change From BL at Day 4	0.13 (1.996)
Change From BL at Day 8	0.19 (3.016)
Change From BL at Day 15	-0.13 (10.379)
Change From BL at Day 29	-0.13 (3.202)
Change From BL at Day 43	-0.13 (3.845)
Change From BL at Day 57	-0.25 (4.712)
Change From BL at Day 71	0.13 (5.353)
Change From BL at Day 85	-0.69 (3.790)
Change From BL at Day 113	1.75 (5.756)
Post-BL Minimum Change From BL	-4.81 (7.901)
Post-BL Maximum Change From BL	5.94 (6.319)

24. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Lactate Dehydrogenase Concentration
Description	Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Time Frame	Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	153.75 (22.228)
Change From BL at Day 2	-10.13 (13.495)
Change From BL at Day 4	-0.19 (15.246)
Change From BL at Day 8	3.19 (11.053)
Change From BL at Day 15	3.19 (17.505)
Change From BL at Day 29	6.56 (17.397)
Change From BL at Day 43	2.38 (11.730)
Change From BL at Day 57	1.69 (11.247)
Change From BL at Day 71	0.19 (15.003)
Change From BL at Day 85	2.63 (16.536)
Change From BL at Day 113	-0.38 (16.141)
Post-BL Minimum Change From BL	-16.06 (11.168)
Post-BL Maximum Change From BL	22.00 (13.765)

25. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Potassium Concentration
Description	Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Time Frame	Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	4.27 (0.351)
Change From BL at Day 2	0.11 (0.401)
Change From BL at Day 4	-0.03 (0.307)
Change From BL at Day 8	0.12 (0.316)
Change From BL at Day 15	-0.02 (0.351)
Change From BL at Day 29	-0.05 (0.337)
Change From BL at Day 43	0.06 (0.366)
Change From BL at Day 57	0.05 (0.507)
Change From BL at Day 71	-0.04 (0.320)
Change From BL at Day 85	-0.19 (0.317)
Change From BL at Day 113	-0.05 (0.371)
Post-BL Minimum Change From BL	-0.47 (0.311)
Post-BL Maximum Change From BL	0.45 (0.248)

26. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Total Protein Concentration
Description	Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Time Frame	Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	70.55 (3.485)
Change From BL at Day 2	-0.18 (4.502)
Change From BL at Day 4	2.69 (3.711)
Change From BL at Day 8	1.36 (3.458)
Change From BL at Day 15	0.81 (3.837)
Change From BL at Day 29	1.03 (2.632)
Change From BL at Day 43	-0.03 (2.452)
Change From BL at Day 57	-1.41 (3.502)
Change From BL at Day 71	0.17 (3.720)
Change From BL at Day 85	-1.13 (4.063)
Change From BL at Day 113	0.71 (3.779)
Post-BL Minimum Change From BL	-3.95 (3.488)
Post-BL Maximum Change From BL	4.54 (2.451)

27. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: SGOT/AST Concentration
Description	Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug. SGOT/AST = serum glutamic-oxaloacetic transaminase/aspartate transaminase
Time Frame	Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	16.63 (2.918)
Change From BL at Day 2	-0.81 (2.007)
Change From BL at Day 4	1.13 (2.941)
Change From BL at Day 8	0.69 (3.240)
Change From BL at Day 15	0.19 (3.728)
Change From BL at Day 29	1.13 (3.304)
Change From BL at Day 43	-0.25 (1.770)
Change From BL at Day 57	0.69 (3.219)
Change From BL at Day 71	-0.31 (2.798)
Change From BL at Day 85	-0.63 (2.778)
Change From BL at Day 113	-0.19 (3.920)
Post-BL Minimum Change From BL	-2.94 (2.594)
Post-BL Maximum Change From BL	4.75 (3.416)

28. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: SGPT/ALT Concentration
Description	Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug. SGPT/ALT = serum glutamic-pyruvic transaminase/alanine transaminase
Time Frame	Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	15.63 (6.449)
Change From BL at Day 2	-0.31 (2.798)
Change From BL at Day 4	2.19 (5.419)
Change From BL at Day 8	2.19 (3.953)
Change From BL at Day 15	-0.13 (7.702)
Change From BL at Day 29	0.25 (6.340)
Change From BL at Day 43	-1.69 (5.199)
Change From BL at Day 57	-1.13 (6.490)
Change From BL at Day 71	-0.50 (6.408)
Change From BL at Day 85	-1.13 (5.560)
Change From BL at Day 113	-0.63 (7.571)
Post-BL Minimum Change From BL	-5.13 (6.206)
Post-BL Maximum Change From BL	8.25 (6.943)

29. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Sodium Concentration
Description	Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Time Frame	Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	140.56 (1.590)
Change From BL at Day 2	-0.44 (1.931)
Change From BL at Day 4	-0.44 (1.931)
Change From BL at Day 8	-0.06 (2.594)
Change From BL at Day 15	0.25 (1.612)
Change From BL at Day 29	-1.75 (2.671)
Change From BL at Day 43	-0.13 (2.062)
Change From BL at Day 57	0.06 (2.932)
Change From BL at Day 71	-1.25 (3.130)
Change From BL at Day 85	-0.38 (2.705)
Change From BL at Day 113	-0.13 (1.893)
Post-BL Minimum Change From BL	-3.38 (2.391)
Post-BL Maximum Change From BL	2.31 (1.922)

30. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Fasting Triglycerides Concentration
Description	Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Time Frame	Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	0.98 (0.446)
Change From BL at Day 2	0.37 (0.377)
Change From BL at Day 4	0.57 (0.517)
Change From BL at Day 8	0.03 (0.350)
Change From BL at Day 15	0.22 (0.497)
Change From BL at Day 29	0.15 (0.382)
Change From BL at Day 43	0.17 (0.278)
Change From BL at Day 57	0.27 (0.726)
Change From BL at Day 71	0.14 (0.314)
Change From BL at Day 85	0.28 (0.395)
Change From BL at Day 113	0.33 (0.429)
Post-BL Minimum Change From BL	-0.19 (0.318)
Post-BL Maximum Change From BL	1.02 (0.490)

31. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Uric Acid Concentration
Description	Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Time Frame	Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	323.44 (52.081)
Change From BL at Day 2	21.38 (28.329)
Change From BL at Day 4	-15.06 (38.979)
Change From BL at Day 8	-2.88 (35.955)
Change From BL at Day 15	2.44 (49.536)
Change From BL at Day 29	2.31 (32.946)
Change From BL at Day 43	9.63 (45.045)
Change From BL at Day 57	9.38 (53.799)
Change From BL at Day 71	33.81 (84.440)
Change From BL at Day 85	19.25 (50.464)
Change From BL at Day 113	34.56 (62.406)
Post-BL Minimum Change From BL	-39.94 (25.870)
Post-BL Maximum Change From BL	79.25 (62.143)

32. Secondary Outcome

Title	Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Activated Partial Thromboplastin Time
Description	Blood samples were collected from participants at the indicated timepoints for evaluation of coagulation parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Time Frame	Baseline and Days 2, 11, 29, 57, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	31.63 (2.111)
Change From BL at Day 2	-2.79 (1.626)
Change From BL at Day 11	-4.82 (1.466)
Change From BL at Day 29	-3.63 (1.643)
Change From BL at Day 57	-2.14 (1.177)
Change From BL at Day 113	-0.70 (1.517)
Post-BL Minimum Change From BL	-4.83 (1.482)
Post-BL Maximum Change From BL	-0.56 (1.463)

33. Secondary Outcome

Title	Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Fibrinogen Concentration
Description	Blood samples were collected from participants at the indicated timepoints for evaluation of coagulation parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Time Frame	Baseline and Days 2, 11, 29, 57 and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	2.43 (0.410)
Change From BL at Day 2	0.18 (0.281)
Change From BL at Day 11	0.28 (0.314)
Change From BL at Day 29	0.11 (0.312)
Change From BL at Day 57	0.05 (0.285)
Change From BL at Day 113	0.07 (0.438)
Post-BL Minimum Change From BL	-0.17 (0.222)
Post-BL Maximum Change From BL	0.53 (0.290)

34. Secondary Outcome

Title	Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Prothrombin Time
Description	Blood samples were collected from participants at the indicated timepoints for evaluation of coagulation parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Time Frame	Baseline and Days 2, 11, 29, 57 and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	11.33 (0.685)
Change From BL at Day 2	0.00 (0.502)
Change From BL at Day 11	-0.09 (0.463)
Change From BL at Day 29	-0.18 (0.455)
Change From BL at Day 57	-0.18 (0.508)
Change From BL at Day 113	-0.17 (0.632)
Post-BL Minimum Change From BL	-0.58 (0.457)
Post-BL Maximum Change From BL	0.37 (0.480)

35. Secondary Outcome

Title	Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Prothrombin Time/International Normalized Ratio (INR)
Description	The INR is a standardized measure of the prothrombin time. Blood samples were collected from participants at the indicated timepoints for evaluation of coagulation parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Time Frame	Baseline and Days 2, 11, 29, 57 and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	1.06 (0.062)
Change From BL at Day 2	0.00 (0.044)
Change From BL at Day 11	-0.01 (0.043)
Change From BL at Day 29	-0.02 (0.042)
Change From BL at Day 57	-0.02 (0.046)
Change From BL at Day 113	-0.02 (0.057)
Post-BL Minimum Change From BL	-0.05 (0.042)
Post-BL Maximum Change From BL	0.03 (0.043)

36. Secondary Outcome

Title	Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils, Absolute Count
Description	Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Time Frame	Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	0.02 (0.018)
Change From BL at Day 2	0.00 (0.013)
Change From BL at Day 4	0.01 (0.018)
Change From BL at Day 8	0.01 (0.029)
Change From BL at Day 15	0.01 (0.022)
Change From BL at Day 29	0.01 (0.014)
Change From BL at Day 43	0.01 (0.023)
Change From BL at Day 57	0.01 (0.016)
Change From BL at Day 71	0.01 (0.022)
Change From BL at Day 85	0.00 (0.021)
Change From BL at Day 113	0.01 (0.019)
Post-BL Minimum Change From BL	-0.01 (0.016)
Post-BL Maximum Change From BL	0.03 (0.021)

37. Secondary Outcome

Title	Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils, Absolute Count
Description	Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Time Frame	Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	0.14 (0.122)
Change From BL at Day 2	0.02 (0.063)
Change From BL at Day 4	0.01 (0.066)
Change From BL at Day 8	0.00 (0.066)
Change From BL at Day 15	-0.01 (0.074)
Change From BL at Day 29	-0.01 (0.055)
Change From BL at Day 43	0.00 (0.101)
Change From BL at Day 57	-0.02 (0.055)
Change From BL at Day 71	0.01 (0.102)
Change From BL at Day 85	-0.02 (0.063)
Change From BL at Day 113	0.02 (0.121)
Post-BL Minimum Change From BL	-0.06 (0.080)
Post-BL Maximum Change From BL	0.07 (0.085)

38. Secondary Outcome

Title	Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Hemoglobin
Description	Erythrocyte mean corpuscular hemoglobin (MCH) is a measure of the average amount of hemoglobin per red blood cell. Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Time Frame	Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	30.84 (1.815)
Change From BL at Day 2	0.23 (0.467)
Change From BL at Day 4	0.09 (0.473)
Change From BL at Day 8	0.26 (0.594)
Change From BL at Day 15	-0.12 (0.472)
Change From BL at Day 29	0.04 (0.507)
Change From BL at Day 43	0.48 (0.493)
Change From BL at Day 57	0.28 (0.567)
Change From BL at Day 71	0.40 (0.625)
Change From BL at Day 85	0.39 (0.738)
Change From BL at Day 113	0.51 (0.933)
Post-BL Minimum Change From BL	-0.40 (0.412)
Post-BL Maximum Change From BL	1.24 (0.730)

39. Secondary Outcome

Title	Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Volume
Description	Erythrocyte mean corpuscular volume is a measure of the average volume of a red blood cell. Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Time Frame	Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	89.79 (3.689)
Change From BL at Day 2	-0.14 (1.172)
Change From BL at Day 4	0.01 (0.954)
Change From BL at Day 8	0.21 (1.138)
Change From BL at Day 15	0.88 (1.036)
Change From BL at Day 29	-0.08 (0.849)
Change From BL at Day 43	1.41 (1.670)
Change From BL at Day 57	1.04 (1.488)
Change From BL at Day 71	0.85 (1.498)
Change From BL at Day 85	0.86 (1.656)
Change From BL at Day 113	0.62 (1.775)
Post-BL Minimum Change From BL	-1.17 (0.899)
Post-BL Maximum Change From BL	2.34 (1.138)

40. Secondary Outcome

Title	Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Hemoglobin Concentration
Description	Erythrocyte mean corpuscular hemoglobin concentration (MCHC) is a measure of the average concentration of hemoglobin per red blood cell. Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Time Frame	Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	343.25 (8.790)
Change From BL at Day 2	3.13 (6.438)
Change From BL at Day 4	1.00 (7.239)
Change From BL at Day 8	2.31 (5.606)
Change From BL at Day 15	-4.56 (6.562)
Change From BL at Day 29	0.69 (6.019)
Change From BL at Day 43	0.13 (8.853)
Change From BL at Day 57	-0.75 (8.798)
Change From BL at Day 71	1.25 (6.372)
Change From BL at Day 85	1.13 (8.277)
Change From BL at Day 113	3.25 (8.004)
Post-BL Minimum Change From BL	-9.00 (6.143)
Post-BL Maximum Change From BL	10.56 (6.099)

41. Secondary Outcome

Title	Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit (as a Fraction of 1)
Description	Hematocrit is a measure of the ratio of red blood cells (RBCs) in the blood by volume. Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Time Frame	Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	0.44 (0.020)
Change From BL at Day 2	0.01 (0.032)
Change From BL at Day 4	0.01 (0.024)
Change From BL at Day 8	0.00 (0.023)
Change From BL at Day 15	0.00 (0.018)
Change From BL at Day 29	-0.01 (0.019)
Change From BL at Day 43	0.00 (0.025)
Change From BL at Day 57	-0.01 (0.027)
Change From BL at Day 71	0.00 (0.027)
Change From BL at Day 85	0.00 (0.029)
Change From BL at Day 113	0.01 (0.029)
Post-BL Minimum Change From BL	-0.02 (0.020)
Post-BL Maximum Change From BL	0.02 (0.022)

42. Secondary Outcome

Title	Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hemoglobin Concentration
Description	Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Time Frame	Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	149.38 (8.065)
Change From BL at Day 2	3.94 (10.056)
Change From BL at Day 4	5.38 (7.571)
Change From BL at Day 8	0.88 (6.551)
Change From BL at Day 15	-2.50 (6.439)
Change From BL at Day 29	-2.50 (7.062)
Change From BL at Day 43	-0.56 (6.345)
Change From BL at Day 57	-1.94 (8.330)
Change From BL at Day 71	0.94 (7.505)
Change From BL at Day 85	0.88 (7.881)
Change From BL at Day 113	3.19 (9.086)
Post-BL Minimum Change From BL	-8.13 (6.076)
Post-BL Maximum Change From BL	9.63 (5.608)

43. Secondary Outcome

Title	Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes, Absolute Count
Description	Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Time Frame	Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	1.65 (0.691)
Change From BL at Day 2	0.10 (0.381)
Change From BL at Day 4	0.37 (0.780)
Change From BL at Day 8	0.04 (0.595)
Change From BL at Day 15	-0.09 (0.599)
Change From BL at Day 29	-0.01 (0.422)
Change From BL at Day 43	0.07 (0.470)
Change From BL at Day 57	0.01 (0.464)
Change From BL at Day 71	0.06 (0.372)
Change From BL at Day 85	0.02 (0.397)
Change From BL at Day 113	0.04 (0.585)
Post-BL Minimum Change From BL	-0.35 (0.447)
Post-BL Maximum Change From BL	0.61 (0.633)

44. Secondary Outcome

Title	Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes, Absolute Count
Description	Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Time Frame	Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	0.35 (0.087)
Change From BL at Day 2	-0.04 (0.098)
Change From BL at Day 4	-0.03 (0.111)
Change From BL at Day 8	-0.04 (0.100)
Change From BL at Day 15	-0.01 (0.136)
Change From BL at Day 29	-0.01 (0.112)
Change From BL at Day 43	-0.03 (0.082)
Change From BL at Day 57	-0.04 (0.091)
Change From BL at Day 71	-0.03 (0.075)
Change From BL at Day 85	-0.04 (0.096)
Change From BL at Day 113	-0.02 (0.112)
Post-BL Minimum Change From BL	-0.10 (0.080)
Post-BL Maximum Change From BL	0.11 (0.112)

45. Secondary Outcome

Title	Change From Baseline in Hematology Laboratory Test Results by Timepoint: Total Neutrophils, Absolute Count
Description	Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Time Frame	Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	3.57 (0.869)
Change From BL at Day 2	-0.24 (0.959)
Change From BL at Day 4	0.12 (0.950)
Change From BL at Day 8	-0.19 (0.809)
Change From BL at Day 15	0.19 (1.043)
Change From BL at Day 29	0.23 (1.063)
Change From BL at Day 43	0.06 (0.961)
Change From BL at Day 57	-0.24 (0.758)
Change From BL at Day 71	-0.06 (0.824)
Change From BL at Day 85	-0.31 (0.686)
Change From BL at Day 113	-0.27 (0.695)
Post-BL Minimum Change From BL	-0.86 (0.708)
Post-BL Maximum Change From BL	1.16 (0.968)

46. Secondary Outcome

Title	Change From Baseline in Hematology Laboratory Test Results by Timepoint: Platelet Count
Description	Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Time Frame	Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	231.50 (47.880)
Change From BL at Day 2	-2.13 (25.469)
Change From BL at Day 4	-3.69 (22.330)
Change From BL at Day 8	0.06 (20.612)
Change From BL at Day 15	7.25 (23.023)
Change From BL at Day 29	12.50 (26.967)
Change From BL at Day 43	9.88 (30.265)
Change From BL at Day 57	10.94 (18.908)
Change From BL at Day 71	5.50 (34.131)
Change From BL at Day 85	0.50 (30.542)
Change From BL at Day 113	2.94 (23.778)
Post-BL Minimum Change From BL	-27.31 (17.984)
Post-BL Maximum Change From BL	36.50 (26.473)

47. Secondary Outcome

Title	Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count
Description	Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Time Frame	Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	4.86 (0.304)
Change From BL at Day 2	0.09 (0.327)
Change From BL at Day 4	0.16 (0.247)
Change From BL at Day 8	-0.02 (0.235)
Change From BL at Day 15	-0.07 (0.196)
Change From BL at Day 29	-0.09 (0.209)
Change From BL at Day 43	-0.09 (0.226)
Change From BL at Day 57	-0.11 (0.289)
Change From BL at Day 71	-0.04 (0.266)
Change From BL at Day 85	-0.04 (0.334)
Change From BL at Day 113	0.02 (0.337)
Post-BL Minimum Change From BL	-0.31 (0.242)
Post-BL Maximum Change From BL	0.26 (0.213)

48. Secondary Outcome

Title	Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count
Description	Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.
Time Frame	Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	5.74 (1.565)
Change From BL at Day 2	-0.17 (1.213)
Change From BL at Day 4	0.33 (1.285)
Change From BL at Day 8	-0.20 (1.222)
Change From BL at Day 15	0.09 (1.400)
Change From BL at Day 29	0.21 (1.026)
Change From BL at Day 43	0.11 (1.162)
Change From BL at Day 57	-0.27 (1.125)
Change From BL at Day 71	-0.01 (1.006)
Change From BL at Day 85	-0.34 (1.064)
Change From BL at Day 113	-0.24 (1.332)
Post-BL Minimum Change From BL	-1.07 (1.071)
Post-BL Maximum Change From BL	1.29 (0.997)

49. Secondary Outcome

Title	Number of Participants by Test Results for Blood in Urine by Timepoint
Description	Urine samples were collected from participants at the indicated timepoints for evaluation of urinalysis parameters. The number of participants with test results for blood in urine of 0 (Absent), +1 (Trace), +2 (Positive), and +3/+4 (Strong Positive) at baseline and each timepoint are reported. Baseline was defined as the participant's last sample prior to initiation of study drug.
Time Frame	Baseline and Days 2, 8, 29, 57, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
0 (Absent)	15 93.8%
+1 (Trace)	1 6.3%
+2 (Positive)	0 0%
+3/+4 (Strong Positive)	0 0%
0 (Absent)	16 100%
+1 (Trace)	0 0%
+2 (Positive)	0 0%
+3/+4 (Strong Positive)	0 0%
0 (Absent)	15 93.8%
+1 (Trace)	1 6.3%
+2 (Positive)	0 0%
+3/+4 (Strong Positive)	0 0%
0 (Absent)	16 100%
+1 (Trace)	0 0%
+2 (Positive)	0 0%
+3/+4 (Strong Positive)	0 0%
0 (Absent)	16 100%
+1 (Trace)	0 0%
+2 (Positive)	0 0%
+3/+4 (Strong Positive)	0 0%
0 (Absent)	16 100%
+1 (Trace)	0 0%
+2 (Positive)	0 0%
+3/+4 (Strong Positive)	0 0%
0 (Absent)	15 93.8%
+1 (Trace)	1 6.3%
+2 (Positive)	0 0%
+3/+4 (Strong Positive)	0 0%

50. Secondary Outcome

Title	Number of Participants by Test Results for Glucose in Urine by Timepoint
Description	Urine samples were collected from participants at the indicated timepoints for evaluation of urinalysis parameters. The number of participants with test results for glucose in urine of 0 (Absent), +1 (Trace), +2 (Positive), and +3/+4 (Strong Positive) at baseline and each timepoint are reported. Baseline was defined as the participant's last sample prior to initiation of study drug.
Time Frame	Baseline and Days 2, 8, 29, 57, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
0 (Absent)	16 100%
+1 (Trace)	0 0%
+2 (Positive)	0 0%
+3/+4 (Strong Positive)	0 0%
0 (Absent)	16 100%
+1 (Trace)	0 0%
+2 (Positive)	0 0%
+3/+4 (Strong Positive)	0 0%
0 (Absent)	16 100%
+1 (Trace)	0 0%
+2 (Positive)	0 0%
+3/+4 (Strong Positive)	0 0%
0 (Absent)	16 100%
+1 (Trace)	0 0%
+2 (Positive)	0 0%
+3/+4 (Strong Positive)	0 0%
0 (Absent)	16 100%
+1 (Trace)	0 0%
+2 (Positive)	0 0%
+3/+4 (Strong Positive)	0 0%
0 (Absent)	16 100%
+1 (Trace)	0 0%
+2 (Positive)	0 0%
+3/+4 (Strong Positive)	0 0%
0 (Absent)	15 93.8%
+1 (Trace)	1 6.3%
+2 (Positive)	0 0%
+3/+4 (Strong Positive)	0 0%

51. Secondary Outcome

Title	Number of Participants by Test Results for Protein in Urine by Timepoint
Description	Urine samples were collected from participants at the indicated timepoints for evaluation of urinalysis parameters. The number of participants with test results for protein in urine of 0 (Absent), +1 (Trace), +2 (Positive), and +3/+4 (Strong Positive) at baseline and each timepoint are reported. Baseline was defined as the participant's last sample prior to initiation of study drug.
Time Frame	Baseline and Days 2, 8, 29, 57, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
0 (Absent)	16 100%
+1 (Trace)	0 0%
+2 (Positive)	0 0%
+3/+4 (Strong Positive)	0 0%
0 (Absent)	16 100%
+1 (Trace)	0 0%
+2 (Positive)	0 0%
+3/+4 (Strong Positive)	0 0%
0 (Absent)	16 100%
+1 (Trace)	0 0%
+2 (Positive)	0 0%
+3/+4 (Strong Positive)	0 0%
0 (Absent)	16 100%
+1 (Trace)	0 0%
+2 (Positive)	0 0%
+3/+4 (Strong Positive)	0 0%
0 (Absent)	15 93.8%
+1 (Trace)	1 6.3%
+2 (Positive)	0 0%
+3/+4 (Strong Positive)	0 0%
0 (Absent)	15 93.8%
+1 (Trace)	1 6.3%
+2 (Positive)	0 0%
+3/+4 (Strong Positive)	0 0%
0 (Absent)	16 100%
+1 (Trace)	0 0%
+2 (Positive)	0 0%
+3/+4 (Strong Positive)	0 0%

52. Secondary Outcome

Title	Change From Baseline in Vital Signs by Timepoint: Diastolic Blood Pressure
Description	Vital signs were measured prior to blood sampling while the participant was in a supine position after they had been resting for at least 5 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.
Time Frame	Baseline and Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	66.1 (5.77)
Change From BL at Day 2	-0.8 (4.99)
Change From BL at Day 4	2.4 (5.21)
Change From BL at Day 6	3.2 (5.43)
Change From BL at Day 8	2.7 (5.41)
Change From BL at Day 11	1.4 (5.11)
Change From BL at Day 15	1.7 (4.24)
Change From BL at Day 22	3.2 (5.46)
Change From BL at Day 29	2.6 (5.67)
Change From BL at Day 36	1.3 (4.48)
Change From BL at Day 43	1.0 (5.18)
Change From BL at Day 50	3.4 (6.49)
Change From BL at Day 57	-0.3 (4.64)
Change From BL at Day 71	1.1 (5.50)
Change From BL at Day 85	1.3 (4.52)
Change From BL at Day 113	1.3 (4.73)
Post-BL Minimum Change From BL	-5.2 (3.08)
Post-BL Maximum Change From BL	8.1 (4.39)

53. Secondary Outcome

Title	Change From Baseline in Vital Signs by Timepoint: Pulse Rate
Description	Vital signs were measured prior to blood sampling while the participant was in a supine position after they had been resting for at least 5 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.
Time Frame	Baseline and Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	61.3 (7.25)
Change From BL at Day 2	-0.6 (4.72)
Change From BL at Day 4	1.3 (4.90)
Change From BL at Day 6	5.8 (7.06)
Change From BL at Day 8	7.7 (8.58)
Change From BL at Day 11	9.9 (10.41)
Change From BL at Day 15	6.9 (5.71)
Change From BL at Day 22	10.2 (9.22)
Change From BL at Day 29	8.4 (9.24)
Change From BL at Day 36	6.3 (7.59)
Change From BL at Day 43	6.2 (7.93)
Change From BL at Day 50	10.4 (6.98)
Change From BL at Day 57	7.5 (6.75)
Change From BL at Day 71	4.7 (7.07)
Change From BL at Day 85	6.9 (9.48)
Change From BL at Day 113	7.4 (8.16)
Post-BL Minimum Change From BL	-3.1 (4.46)
Post-BL Maximum Change From BL	18.1 (6.29)

54. Secondary Outcome

Title	Change From Baseline in Vital Signs by Timepoint: Respiratory Rate
Description	Vital signs were measured prior to blood sampling while the participant was in a supine position after they had been resting for at least 5 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.
Time Frame	Baseline and Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	15.5 (1.51)
Change From BL at Day 2	0.6 (1.50)
Change From BL at Day 4	0.3 (1.89)
Change From BL at Day 6	-0.5 (2.00)
Change From BL at Day 8	0.8 (2.64)
Change From BL at Day 11	0.1 (2.55)
Change From BL at Day 15	-0.1 (2.38)
Change From BL at Day 22	-0.1 (2.60)
Change From BL at Day 29	0.2 (2.10)
Change From BL at Day 36	0.9 (1.54)
Change From BL at Day 43	-0.3 (1.88)
Change From BL at Day 50	0.3 (2.32)
Change From BL at Day 57	0.2 (2.14)
Change From BL at Day 71	-0.3 (2.02)
Change From BL at Day 85	-0.4 (2.33)
Change From BL at Day 113	0.4 (2.47)
Post-BL Minimum Change From BL	-3.0 (1.83)
Post-BL Maximum Change From BL	2.7 (1.82)

55. Secondary Outcome

Title	Change From Baseline in Vital Signs by Timepoint: Systolic Blood Pressure
Description	Vital signs were measured prior to blood sampling while the participant was in a supine position after they had been resting for at least 5 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.
Time Frame	Baseline and Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	106.8 (7.26)
Change From BL at Day 2	-1.6 (6.49)
Change From BL at Day 4	2.4 (5.82)
Change From BL at Day 6	3.6 (5.86)
Change From BL at Day 8	3.5 (8.16)
Change From BL at Day 11	5.1 (8.05)
Change From BL at Day 15	2.5 (4.97)
Change From BL at Day 22	4.8 (7.46)
Change From BL at Day 29	3.2 (8.84)
Change From BL at Day 36	2.2 (7.49)
Change From BL at Day 43	2.0 (5.97)
Change From BL at Day 50	5.2 (8.95)
Change From BL at Day 57	2.2 (7.19)
Change From BL at Day 71	1.2 (6.35)
Change From BL at Day 85	2.0 (8.68)
Change From BL at Day 113	1.1 (8.75)
Post-BL Minimum Change From BL	-4.6 (5.76)
Post-BL Maximum Change From BL	10.9 (7.47)

56. Secondary Outcome

Title	Change From Baseline in Vital Signs by Timepoint: Temperature (Axillary)
Description	Vital signs were measured prior to blood sampling while the participant was in a supine position after they had been resting for at least 5 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.
Time Frame	Baseline and Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	36.20 (0.239)
Change From BL at Day 2	-0.12 (0.281)
Change From BL at Day 4	0.01 (0.263)
Change From BL at Day 6	-0.09 (0.532)
Change From BL at Day 8	-0.08 (0.217)
Change From BL at Day 11	-0.18 (0.414)
Change From BL at Day 15	-0.06 (0.515)
Change From BL at Day 22	-0.14 (0.352)
Change From BL at Day 29	-0.11 (0.433)
Change From BL at Day 36	-0.19 (0.313)
Change From BL at Day 43	-0.16 (0.318)
Change From BL at Day 50	-0.16 (0.418)
Change From BL at Day 57	0.02 (0.382)
Change From BL at Day 71	-0.09 (0.360)
Change From BL at Day 85	-0.21 (0.260)
Change From BL at Day 113	-0.02 (0.297)
Post-BL Minimum Change From BL	-0.61 (0.260)
Post-BL Maximum Change From BL	0.43 (0.357)

57. Secondary Outcome

Title	Change From Baseline in Electrocardiogram (ECG) Results by Timepoint: Heart Rate
Description	The 12-lead electrocardiogram (ECG) measurements were collected in triplicate (three consecutive interpretable ECGs within 5 minutes) after the participant had been in a supine position for at least 10 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.
Time Frame	Baseline and Days 2, 4, 6, 8, 15, 29, 43, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	59.90 (5.588)
Change From BL at Day 2	-0.67 (3.656)
Change From BL at Day 4	2.50 (3.978)
Change From BL at Day 6	6.52 (6.491)
Change From BL at Day 8	8.63 (7.574)
Change From BL at Day 15	6.58 (4.250)
Change From BL at Day 29	8.10 (8.675)
Change From BL at Day 43	6.96 (7.946)
Change From BL at Day 57	6.42 (5.793)
Change From BL at Day 71	5.42 (6.976)
Change From BL at Day 85	8.25 (8.234)
Change From BL at Day 113	7.15 (6.442)
Post-BL Minimum Change From BL	-2.21 (2.638)
Post-BL Maximum Change From BL	15.52 (6.259)

58. Secondary Outcome

Title	Change From Baseline in ECG Results by Timepoint: PR Duration
Description	The 12-lead electrocardiogram (ECG) measurements were collected in triplicate (three consecutive interpretable ECGs within 5 minutes) after the participant had been in a supine position for at least 10 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.
Time Frame	Baseline and Days 2, 4, 6, 8, 15, 29, 43, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	160.21 (16.023)
Change From BL at Day 2	0.81 (12.767)
Change From BL at Day 4	-0.10 (9.229)
Change From BL at Day 6	-1.90 (9.998)
Change From BL at Day 8	-4.13 (12.692)
Change From BL at Day 15	-1.73 (14.577)
Change From BL at Day 29	-4.10 (10.197)
Change From BL at Day 43	-1.79 (13.850)
Change From BL at Day 57	-1.52 (10.352)
Change From BL at Day 71	-1.29 (9.008)
Change From BL at Day 85	-5.02 (12.450)
Change From BL at Day 113	-1.52 (6.576)
Post-BL Minimum Change From BL	-15.21 (11.517)
Post-BL Maximum Change From BL	8.83 (9.000)

59. Secondary Outcome

Title	Change From Baseline in ECG Results by Timepoint: QRS Duration
Description	The 12-lead electrocardiogram (ECG) measurements were collected in triplicate (three consecutive interpretable ECGs within 5 minutes) after the participant had been in a supine position for at least 10 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.
Time Frame	Baseline and Days 2, 4, 6, 8, 15, 29, 43, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	98.15 (9.074)
Change From BL at Day 2	0.75 (5.514)
Change From BL at Day 4	1.40 (3.077)
Change From BL at Day 6	-0.71 (3.052)
Change From BL at Day 8	-0.48 (4.169)
Change From BL at Day 15	-0.40 (3.221)
Change From BL at Day 29	-1.00 (5.594)
Change From BL at Day 43	-0.65 (2.327)
Change From BL at Day 57	-1.54 (2.494)
Change From BL at Day 71	0.77 (3.429)
Change From BL at Day 85	-0.46 (3.494)
Change From BL at Day 113	-0.92 (3.782)
Post-BL Minimum Change From BL	-4.19 (3.592)
Post-BL Maximum Change From BL	4.50 (3.475)

60. Secondary Outcome

Title	Change From Baseline in ECG Results by Timepoint: QT Duration
Description	The 12-lead electrocardiogram (ECG) measurements were collected in triplicate (three consecutive interpretable ECGs within 5 minutes) after the participant had been in a supine position for at least 10 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.
Time Frame	Baseline and Days 2, 4, 6, 8, 15, 29, 43, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	398.31 (27.123)
Change From BL at Day 2	-1.35 (11.351)
Change From BL at Day 4	-10.00 (13.856)
Change From BL at Day 6	-12.31 (19.791)
Change From BL at Day 8	-15.69 (15.037)
Change From BL at Day 15	-9.90 (13.857)
Change From BL at Day 29	-11.83 (19.322)
Change From BL at Day 43	-11.96 (13.863)
Change From BL at Day 57	-7.56 (16.498)
Change From BL at Day 71	-4.94 (19.933)
Change From BL at Day 85	-9.75 (23.282)
Change From BL at Day 113	-9.21 (20.349)
Post-BL Minimum Change From BL	-30.35 (14.706)
Post-BL Maximum Change From BL	9.60 (12.064)

61. Secondary Outcome

Title	Change From Baseline in ECG Results by Timepoint: QTcB Duration (Bazett's Correction Formula)
Description	The 12-lead electrocardiogram (ECG) measurements were collected in triplicate (three consecutive interpretable ECGs within 5 minutes) after the participant had been in a supine position for at least 10 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.
Time Frame	Baseline and Days 2, 4, 6, 8, 15, 29, 43, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	398.04 (19.275)
Change From BL at Day 2	-3.81 (10.367)
Change From BL at Day 4	-2.29 (8.759)
Change From BL at Day 6	7.33 (8.549)
Change From BL at Day 8	10.08 (13.968)
Change From BL at Day 15	10.50 (10.870)
Change From BL at Day 29	12.69 (12.031)
Change From BL at Day 43	8.81 (13.699)
Change From BL at Day 57	12.00 (9.509)
Change From BL at Day 71	12.25 (12.194)
Change From BL at Day 85	15.27 (13.029)
Change From BL at Day 113	12.08 (13.229)
Post-BL Minimum Change From BL	-7.27 (8.817)
Post-BL Maximum Change From BL	24.23 (11.165)

62. Secondary Outcome

Title	Change From Baseline in ECG Results by Timepoint: QTcF Duration (Fridericia's Correction Formula)
Description	The 12-lead electrocardiogram (ECG) measurements were collected in triplicate (three consecutive interpretable ECGs within 5 minutes) after the participant had been in a supine position for at least 10 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.
Time Frame	Baseline and Days 2, 4, 6, 8, 15, 29, 43, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	397.90 (20.554)
Change From BL at Day 2	-2.98 (8.968)
Change From BL at Day 4	-4.94 (9.038)
Change From BL at Day 6	1.21 (9.739)
Change From BL at Day 8	1.31 (9.708)
Change From BL at Day 15	3.56 (10.109)
Change From BL at Day 29	4.33 (8.384)
Change From BL at Day 43	1.69 (8.274)
Change From BL at Day 57	5.31 (8.893)
Change From BL at Day 71	6.40 (11.109)
Change From BL at Day 85	6.71 (12.243)
Change From BL at Day 113	4.81 (12.931)
Post-BL Minimum Change From BL	-8.21 (8.174)
Post-BL Maximum Change From BL	14.77 (10.366)

63. Secondary Outcome

Title	Change From Baseline in ECG Results by Timepoint: RR Duration
Description	The 12-lead electrocardiogram (ECG) measurements were collected in triplicate (three consecutive interpretable ECGs within 5 minutes) after the participant had been in a supine position for at least 10 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.
Time Frame	Baseline and Days 2, 4, 6, 8, 15, 29, 43, 57, 71, 85, and 113

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Baseline (BL) - Value at Visit	1001.06 (93.082)
Change From BL at Day 2	12.73 (66.160)
Change From BL at Day 4	-36.04 (60.573)
Change From BL at Day 6	-94.79 (99.788)
Change From BL at Day 8	-119.67 (106.349)
Change From BL at Day 15	-96.56 (67.805)
Change From BL at Day 29	-114.08 (126.347)
Change From BL at Day 43	-97.98 (109.011)
Change From BL at Day 57	-92.98 (87.990)
Change From BL at Day 71	-82.29 (112.001)
Change From BL at Day 85	-115.87 (122.073)
Change From BL at Day 113	-101.02 (98.269)
Post-BL Minimum Change From BL	-205.40 (91.026)
Post-BL Maximum Change From BL	40.25 (49.296)

64. Secondary Outcome

Title	Number of Participants With Concomitant Medications
Description	The original terms recorded by the investigator for concomitant medications were standardized by the sponsor by assigning preferred terms. The duration of treatment with the concomitant medications ranged from 1 day to 5 days. Except for 1 participant who was treated during the in-clinic period (Days -1 to 4), all other concomitant medications were recorded during the ambulatory period (Days 6 to 113).
Time Frame	From screening to study completion (20 weeks)

Outcome Measure Data

Analysis Population Description
The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Measure Participants	16
Total Participants with at Least 1 Treatment	6 37.5%
Analgesics - Paracetamol	1 6.3%
Antitrichomonal Agents - Tinidazole	1 6.3%
Cephalosporin Antibiotics - Cefadroxil	1 6.3%
Cephalosporin Antibiotics - Cefminox	1 6.3%
Herbal, Homeopathic, and Dietary Supplements	1 6.3%
Non-Steroidal Anti-Inflammatories - Pranoprofen	1 6.3%
Proton Pump Inhibitors - Pantoprazole	1 6.3%
Salicylates - Aspirin DL-Lysine	1 6.3%
Supplements - Potassium Chloride	1 6.3%
Supplements - Sodium Chloride	1 6.3%
Vitamins and Minerals - Ascorbic Acid	1 6.3%

Adverse Events

	Emicizumab
Time Frame	From screening to study completion (20 weeks)
Adverse Event Reporting Description	Investigators sought information on adverse events (AEs) at each contact with participants. After informed consent but prior to initiation of study drug, only serious AEs (SAEs) caused by a protocol-mandated intervention were to be reported. After initiation of study drug, all AEs, regardless of relationship to study drug, were to be reported until the participant completed his last study visit. After this period, any SAEs believed to be related to prior study drug treatment were to be reported.

Arm/Group Title	Emicizumab
Arm/Group Description	Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
All Cause Mortality
	Affected / at Risk (%)	# Events
Total	0/16 (0%)
Serious Adverse Events
	Emicizumab
	Affected / at Risk (%)	# Events
Total	0/16 (0%)
Other (Not Including Serious) Adverse Events
	Emicizumab
	Affected / at Risk (%)	# Events
Total	14/16 (87.5%)
Blood and lymphatic system disorders
Leukopenia	1/16 (6.3%)
Gastrointestinal disorders
Diarrhoea	1/16 (6.3%)
Flatulence	1/16 (6.3%)
Mouth ulceration	1/16 (6.3%)
Toothache	1/16 (6.3%)
Infections and infestations
Upper respiratory tract infection	4/16 (25%)
Conjunctivitis	1/16 (6.3%)
Gastroenteritis	1/16 (6.3%)
Pericoronitis	1/16 (6.3%)
Injury, poisoning and procedural complications
Injury	1/16 (6.3%)
Road traffic accident	1/16 (6.3%)
Investigations
Blood creatinine phosphokinase increased	4/16 (25%)
C-reactive protein increased	2/16 (12.5%)
Blood bilirubin increased	1/16 (6.3%)
Blood triglycerides increased	1/16 (6.3%)
Blood uric acid increased	1/16 (6.3%)
White blood cell count decreased	1/16 (6.3%)
White blood cell count increased	1/16 (6.3%)
Metabolism and nutrition disorders
Hypertriglyceridaemia	1/16 (6.3%)
Hypokalaemia	1/16 (6.3%)
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain	3/16 (18.8%)
Cough	1/16 (6.3%)
Dry throat	1/16 (6.3%)
Nasal congestion	1/16 (6.3%)
Nasal obstruction	1/16 (6.3%)
Skin and subcutaneous tissue disorders
Rash	1/16 (6.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.

Results Point of Contact

Name/Title	Medical Communications
Organization	Hoffmann-La Roche
Phone	800-821-8590
Email	genentech@druginfo.com

Responsible Party:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT03380780

Other Study ID Numbers:

YP39308

First Posted:

Dec 21, 2017

Last Update Posted:

Sep 30, 2019

Last Verified:

Sep 1, 2019