Safety and Tolerability of MEDI9314 as Single Ascending Dose in Healthy Subjects
Sponsor
MedImmune LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT02669667
Collaborator
(none)
44
2
6
15.8
22
1.4
Study Details
Study Description
Brief Summary
This is a phase 1a randomized, blinded, placebo-controlled, single-ascending dose study to assess the safety and tolerability of MEDI9314 in healthy adult subjects
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
This is a phase I study to assess the safety, tolerability pharmacokinetics, and immunogenicity of MEDI9314 following single dose administration to healthy subjects
Study Design
Study Type:
Interventional
Actual Enrollment
:
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
A Phase 1a Randomized, Blinded, Placebo-controlled, Single-ascending Dose Study to Evaluate the Safety and Tolerability of MEDI9314 in Healthy Adult Subjects
Actual Study Start Date
:
Feb 18, 2016
Actual Primary Completion Date
:
Nov 17, 2016
Actual Study Completion Date
:
Jun 12, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cohort 1 single dose of MEDI9314 or placebo |
Drug: MEDI9314
single dose of MEDI9314
Drug: placebo
single dose of placebo
|
| Experimental: Cohort 2 single dose of MEDI9314 or placebo |
Drug: MEDI9314
single dose of MEDI9314
Drug: placebo
single dose of placebo
|
| Experimental: Cohort 3 single dose of MEDI9314 or placebo |
Drug: MEDI9314
single dose of MEDI9314
Drug: placebo
single dose of placebo
|
| Experimental: Cohort 4 single dose of MEDI9314 or placebo |
Drug: MEDI9314
single dose of MEDI9314
Drug: placebo
single dose of placebo
|
| Experimental: Japanese Cohort single dose of MEDI9314 or placebo |
Drug: MEDI9314
single dose of MEDI9314
Drug: placebo
single dose of placebo
|
| Experimental: Cohort 5 single dose of MEDI9314 or placebo |
Drug: MEDI9314
single dose of MEDI9314
Drug: placebo
single dose of placebo
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) [From the start of study drug administration upto Day 240]
An adverse event is any unfavourable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with use of medicinal product, whether or not considered related to medicinal product. Serious adverse event is any AE that resulted in death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug and up to Day 240.
- Number of Participants With Electrocardiogram Abnormalities Reported as TEAEs [From the start of study drug administration upto Day 240]
TEAEs observed in participants with clinically significant ECG abnormalities were reported.
- Number of Participants With Vital Signs Abnormalities Reported as TEAEs [From the start of study drug administration upto Day 240]
Vital sign parameters included blood pressure, heart rate, and temperature. TEAEs observed in participants with clinically significant vital signs abnormalities were reported.
- Number of Participants With Physical Examination Abnormalities Reported as TEAEs [From the start of study drug administration upto Day 240]
Adverse events observed in participants with clinically significant physical abnormalities were assessed.
- Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs [From the start of study drug administration upto Day 240]
An abnormal laboratory finding which required an action or medical intervention by the investigator, or a finding judged by the investigator as medically significant should be reported as an adverse event. Laboratory evaluation (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.
- Number of Participants With TEAEs Related to Injection Site Reactions [From the start of study drug administration upto Day 240]
Adverse events of special interest observed in participants with clinically significant injection site reaction were assessed.
Secondary Outcome Measures
- Area Under the Serum Drug Concentration Versus Time Curves From Zero to Infinity (AUC 0-inf) of MEDI9314 [Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240]
The area under the serum drug concentration versus time curves from zero to infinity of MEDI9314.
- Area Under the Serum Drug Concentration Versus Time Curve, to Last Quantifiable Time Point (AUClast) [Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240]
The area under the serum drug concentration versus time curve, to last quantifiable time point of MEDI9314.
- Maximum Observed Serum Drug Concentration (Cmax) of MEDI9314 [Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240]
The maximum observed serum drug concentration of MEDI9314.
- Time to Maximum Observed Serum Drug Concentration (Tmax) of MEDI9314 [Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240]
The time to maximum observed serum drug concentration of MEDI9314.
- Terminal Phase Elimination Half-life (t1/2) of MEDI9314 [Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240]
Terminal phase elimination half-life of MEDI9314
- Serum Concentrations of MEDI9314 [Baseline (Day 1 [predose]) and Day 240]
Baseline indicates the last assessment prior to first dose. For this study, the lower limit of quantification (LLOQ) for MEDI9314 serum concentrations were 19.53 μg/mL. Where serum concentrations were below this value, a serum concentration of 9.770 μg/mL was imputed.
- Number of Participants Positive for Anti-Drug Antibodies to MEDI9314 [Baseline (Day 1 [predose]) and Day 240]
Blood samples for immunogenicity assessment included the determination of anti-drug antibodies (ADA) for MEDI9314. The number of participants with positive serum antibodies to MEDI9314 were presented.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Written informed consent.
-
Age 18 through 50 years at the time of screening.
-
Female subjects must be of non-childbearing potential.
-
Nonsterilized males who are sexually active with a female partner of childbearing potential must use condom and spermicide.
-
Body mass index of 19.0 through 32.0 kg/m2 at screening.
-
No clinically significant abnormality on the basis of medical/medication history or physical examination.
-
Negative drugs of abuse (DOA).
-
Able and willing to comply with the requirements of the protocol and complete the study until the end of the safety follow up period.
-
For the Japanese Cohort, both of the subject's parents and both sets of grandparents must be Japanese.
Exclusion Criteria:
-
Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
-
Concurrent enrollment in another clinical study involving any treatment.
-
Individuals who are legally institutionalized.
-
Receipt of > 2 marketed or investigational biologic agents.
-
Receipt of an investigational biologic agent within 4 months or 5 half-lives prior to screening, whichever is longer.
-
Receipt of any investigational non biologic agent within 3 months or 5 half lives prior to screening, whichever is longer.
-
Use of any medication (prescription or over the counter, including herbal remedies) within 14 days or 5 half lives of Day 1, whichever is longer, unless in the opinion of the investigator and medical monitor the medication will not interfere with the study procedures or compromise subject safety.
-
Known history of allergy or reaction to any component of the investigational product formulation.
-
History of anaphylaxis following any biologic therapy.
-
Any clinically relevant abnormal findings in physical examination ECG, vital signs, and laboratory parameters.
-
Positive tuberculosis (TB) test (QuantiFERON®-TB Gold In-tube).
-
Positive hepatitis B surface antigen, hepatitis C virus antibody or HIV test at screening.
-
Receipt of live attenuated vaccines 30 days prior to the date of screening.
-
Where donation of blood or blood products was in excess of 500 mL within an 8-week period in the 3 months prior to screening.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Glendale | California | United States | 91206 |
| 2 | Research Site | Harrow | United Kingdom | HA1 3UJ |
Sponsors and Collaborators
- MedImmune LLC
Investigators
- Principal Investigator: Muna Albayaty, MBChB, FFPM, Parexel
- Principal Investigator: Hakop Gevorkyan, MD, Parexel
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT02669667
Other Study ID Numbers:
- D4361C00002
First Posted:
Feb 1, 2016
Last Update Posted:
Jun 4, 2019
Last Verified:
May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by MedImmune LLC
Study Results
Participant Flow
| Recruitment Details | The study was conducted from 18Feb2016 to 12Jun2017 in United States and United Kingdom. |
|---|---|
| Pre-assignment Detail | A total of 124 participants were enrolled in the study; of which 80 participants were screen failures. Forty-four participants were randomized to MEDI9314 or placebo" in 7 treatment groups. |
| Arm/Group Title | Placebo | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 | Cohort 6 |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1. | Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1. | Participants received a single SC injection of MEDI9314 150 mg on Day 1. | Participants received a single SC injection of MEDI9314 300 mg on Day 1. | Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1 | Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose. | Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. |
| Period Title: Overall Study | |||||||
| STARTED | 12 | 4 | 4 | 6 | 6 | 6 | 6 |
| COMPLETED | 12 | 4 | 4 | 6 | 6 | 5 | 6 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline Characteristics
| Arm/Group Title | Placebo | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 | Cohort 6 | Total |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1. | Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1. | Participants received a single SC injection of MEDI9314 150 mg on Day 1. | Participants received a single SC injection of MEDI9314 300 mg on Day 1. | Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1 | Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose. | Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. | Total of all reporting groups |
| Overall Participants | 12 | 4 | 4 | 6 | 6 | 6 | 6 | 44 |
| Age (Years) [Mean (Standard Deviation) ] | ||||||||
| Mean (Standard Deviation) [Years] |
33.8
(10.2)
|
32.0
(12.1)
|
28.0
(5.1)
|
32.0
(8.6)
|
35.0
(5.3)
|
31.2
(8.2)
|
36.0
(10.5)
|
33.0
(8.7)
|
| Sex: Female, Male (Count of Participants) | ||||||||
| Female |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Male |
12
100%
|
4
100%
|
4
100%
|
6
100%
|
6
100%
|
6
100%
|
6
100%
|
44
100%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||||||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
16.7%
|
1
16.7%
|
2
4.5%
|
| Not Hispanic or Latino |
12
100%
|
4
100%
|
4
100%
|
6
100%
|
6
100%
|
5
83.3%
|
5
83.3%
|
42
95.5%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
3
25%
|
1
25%
|
0
0%
|
0
0%
|
6
100%
|
1
16.7%
|
0
0%
|
11
25%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
1
8.3%
|
2
50%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
16.7%
|
4
9.1%
|
| White |
8
66.7%
|
1
25%
|
4
100%
|
6
100%
|
0
0%
|
4
66.7%
|
5
83.3%
|
28
63.6%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
16.7%
|
0
0%
|
1
2.3%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) |
|---|---|
| Description | An adverse event is any unfavourable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with use of medicinal product, whether or not considered related to medicinal product. Serious adverse event is any AE that resulted in death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug and up to Day 240. |
| Time Frame | From the start of study drug administration upto Day 240 |
Outcome Measure Data
| Analysis Population Description |
|---|
| As-treated population included participants who received any study drug and summarized according to the treatment they actually received. |
| Arm/Group Title | Placebo | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 | Cohort 6 |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1. | Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1. | Participants received a single SC injection of MEDI9314 150 mg on Day 1. | Participants received a single SC injection of MEDI9314 300 mg on Day 1. | Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1 | Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose. | Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. |
| Measure Participants | 12 | 4 | 4 | 6 | 6 | 6 | 6 |
| TEAEs |
8
66.7%
|
4
100%
|
2
50%
|
5
83.3%
|
4
66.7%
|
5
83.3%
|
5
83.3%
|
| TESAEs |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Number of Participants With Electrocardiogram Abnormalities Reported as TEAEs |
|---|---|
| Description | TEAEs observed in participants with clinically significant ECG abnormalities were reported. |
| Time Frame | From the start of study drug administration upto Day 240 |
Outcome Measure Data
| Analysis Population Description |
|---|
| As-treated population included participants who received any study drug and summarized according to the treatment they actually received. |
| Arm/Group Title | Placebo | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 | Cohort 6 |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1. | Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1. | Participants received a single SC injection of MEDI9314 150 mg on Day 1. | Participants received a single SC injection of MEDI9314 300 mg on Day 1. | Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1 | Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose. | Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. |
| Measure Participants | 12 | 4 | 4 | 6 | 6 | 6 | 6 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Number of Participants With Vital Signs Abnormalities Reported as TEAEs |
|---|---|
| Description | Vital sign parameters included blood pressure, heart rate, and temperature. TEAEs observed in participants with clinically significant vital signs abnormalities were reported. |
| Time Frame | From the start of study drug administration upto Day 240 |
Outcome Measure Data
| Analysis Population Description |
|---|
| As-treated population included participants who received any study drug and summarized according to the treatment they actually received. |
| Arm/Group Title | Placebo | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 | Cohort 6 |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1. | Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1. | Participants received a single SC injection of MEDI9314 150 mg on Day 1. | Participants received a single SC injection of MEDI9314 300 mg on Day 1. | Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1 | Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose. | Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. |
| Measure Participants | 12 | 4 | 4 | 6 | 6 | 6 | 6 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
1
16.7%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Number of Participants With Physical Examination Abnormalities Reported as TEAEs |
|---|---|
| Description | Adverse events observed in participants with clinically significant physical abnormalities were assessed. |
| Time Frame | From the start of study drug administration upto Day 240 |
Outcome Measure Data
| Analysis Population Description |
|---|
| As-treated population included participants who received any study drug and summarized according to the treatment they actually received. |
| Arm/Group Title | Placebo | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 | Cohort 6 |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1. | Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1. | Participants received a single SC injection of MEDI9314 150 mg on Day 1. | Participants received a single SC injection of MEDI9314 300 mg on Day 1. | Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1 | Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose. | Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. |
| Measure Participants | 12 | 4 | 4 | 6 | 6 | 6 | 6 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs |
|---|---|
| Description | An abnormal laboratory finding which required an action or medical intervention by the investigator, or a finding judged by the investigator as medically significant should be reported as an adverse event. Laboratory evaluation (haematology, serum chemistry and urinalysis) of blood and urine samples were performed. |
| Time Frame | From the start of study drug administration upto Day 240 |
Outcome Measure Data
| Analysis Population Description |
|---|
| As-treated population included participants who received any study drug and summarized according to the treatment they actually received. |
| Arm/Group Title | Placebo | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 | Cohort 6 |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1. | Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1. | Participants received a single SC injection of MEDI9314 150 mg on Day 1. | Participants received a single SC injection of MEDI9314 300 mg on Day 1. | Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1 | Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose. | Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. |
| Measure Participants | 12 | 4 | 4 | 6 | 6 | 6 | 6 |
| Liver function test increased |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
16.7%
|
0
0%
|
0
0%
|
| Transaminases increased |
1
8.3%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Number of Participants With TEAEs Related to Injection Site Reactions |
|---|---|
| Description | Adverse events of special interest observed in participants with clinically significant injection site reaction were assessed. |
| Time Frame | From the start of study drug administration upto Day 240 |
Outcome Measure Data
| Analysis Population Description |
|---|
| As-treated population included participants who received any study drug and summarized according to the treatment they actually received. |
| Arm/Group Title | Placebo | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 | Cohort 6 |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1. | Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1. | Participants received a single SC injection of MEDI9314 150 mg on Day 1. | Participants received a single SC injection of MEDI9314 300 mg on Day 1. | Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1 | Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose. | Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. |
| Measure Participants | 12 | 4 | 4 | 6 | 6 | 6 | 6 |
| Infusion site bruising |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
16.7%
|
0
0%
|
| Infusion site erythema |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
16.7%
|
0
0%
|
| Infusion site pruritus |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
16.7%
|
0
0%
|
| Injection site bruising |
1
8.3%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Injection site erythema |
2
16.7%
|
4
100%
|
1
25%
|
5
83.3%
|
0
0%
|
0
0%
|
0
0%
|
| Injection site haemorrhage |
1
8.3%
|
0
0%
|
1
25%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Injection site induration |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
4
66.7%
|
0
0%
|
0
0%
|
| Injection site pain |
0
0%
|
0
0%
|
0
0%
|
1
16.7%
|
0
0%
|
0
0%
|
0
0%
|
| Injection site pruritus |
0
0%
|
0
0%
|
1
25%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Injection site warmth |
1
8.3%
|
0
0%
|
1
25%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Area Under the Serum Drug Concentration Versus Time Curves From Zero to Infinity (AUC 0-inf) of MEDI9314 |
|---|---|
| Description | The area under the serum drug concentration versus time curves from zero to infinity of MEDI9314. |
| Time Frame | Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic (PK) population included all participants in the as-treated population who received MEDI9314 and who have detectable post-dosing MEDI9314 serum concentrations for accurate estimation of PK parameters. The "Number Analyzed" denotes the number of participants evaluated for this outcome measure. |
| Arm/Group Title | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 | Cohort 6 |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1. | Participants received a single SC injection of MEDI9314 150 mg on Day 1. | Participants received a single SC injection of MEDI9314 300 mg on Day 1. | Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1 | Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose. | Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. |
| Measure Participants | 4 | 4 | 6 | 6 | 6 | 6 |
| Mean (Standard Deviation) [µg*d/mL] |
3.01
(NA)
|
68.8
(47.3)
|
179
(105)
|
264
(159)
|
668
(132)
|
1440
(126)
|
| Title | Area Under the Serum Drug Concentration Versus Time Curve, to Last Quantifiable Time Point (AUClast) |
|---|---|
| Description | The area under the serum drug concentration versus time curve, to last quantifiable time point of MEDI9314. |
| Time Frame | Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PK population included all participants in the as-treated population who received MEDI9314 and who have detectable post-dosing MEDI9314 serum concentrations for accurate estimation of PK parameters. The "Number Analyzed" denotes the number of participants evaluated for this outcome measure. |
| Arm/Group Title | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 | Cohort 6 |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1. | Participants received a single SC injection of MEDI9314 150 mg on Day 1. | Participants received a single SC injection of MEDI9314 300 mg on Day 1. | Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1 | Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose. | Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. |
| Measure Participants | 4 | 4 | 6 | 6 | 6 | 6 |
| Mean (Standard Deviation) [μg*d/mL] |
2.94
(NA)
|
68.6
(47.3)
|
178
(105)
|
264
(159)
|
667
(132)
|
1439
(126)
|
| Title | Maximum Observed Serum Drug Concentration (Cmax) of MEDI9314 |
|---|---|
| Description | The maximum observed serum drug concentration of MEDI9314. |
| Time Frame | Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240 |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK population included all participants in the as-treated population who received MEDI9314 and who have detectable post-dosing MEDI9314 serum concentrations for accurate estimation of PK parameters. |
| Arm/Group Title | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 | Cohort 6 |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1. | Participants received a single SC injection of MEDI9314 150 mg on Day 1. | Participants received a single SC injection of MEDI9314 300 mg on Day 1. | Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1 | Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose. | Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. |
| Measure Participants | 4 | 4 | 6 | 6 | 6 | 6 |
| Mean (Standard Deviation) [µg/mL] |
0.425
(0.367)
|
5.44
(2.77)
|
10.4
(5.63)
|
14.1
(8.87)
|
79.0
(14.8)
|
108
(9.99)
|
| Title | Time to Maximum Observed Serum Drug Concentration (Tmax) of MEDI9314 |
|---|---|
| Description | The time to maximum observed serum drug concentration of MEDI9314. |
| Time Frame | Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240 |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK population included all participants in the as-treated population who received MEDI9314 and who have detectable post-dosing MEDI9314 serum concentrations for accurate estimation of PK parameters. |
| Arm/Group Title | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 | Cohort 6 |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1. | Participants received a single SC injection of MEDI9314 150 mg on Day 1. | Participants received a single SC injection of MEDI9314 300 mg on Day 1. | Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1 | Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose. | Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. |
| Measure Participants | 4 | 4 | 6 | 6 | 6 | 6 |
| Median (Full Range) [Day] |
4.00
|
8.07
|
5.52
|
5.51
|
0.04
|
0.04
|
| Title | Terminal Phase Elimination Half-life (t1/2) of MEDI9314 |
|---|---|
| Description | Terminal phase elimination half-life of MEDI9314 |
| Time Frame | Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PK population included all participants in the as-treated population who received MEDI9314 and who have detectable post-dosing MEDI9314 serum concentrations for accurate estimation of PK parameters. The "Number Analyzed" denotes the number of participants evaluated for this outcome measure. |
| Arm/Group Title | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 | Cohort 6 |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1. | Participants received a single SC injection of MEDI9314 150 mg on Day 1. | Participants received a single SC injection of MEDI9314 300 mg on Day 1. | Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1 | Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose. | Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. |
| Measure Participants | 4 | 4 | 6 | 6 | 6 | 6 |
| Mean (Standard Deviation) [Day] |
1.74
(NA)
|
3.55
(0.685)
|
4.72
(0.998)
|
5.03
(1.13)
|
7.31
(1.29)
|
8.95
(1.14)
|
| Title | Serum Concentrations of MEDI9314 |
|---|---|
| Description | Baseline indicates the last assessment prior to first dose. For this study, the lower limit of quantification (LLOQ) for MEDI9314 serum concentrations were 19.53 μg/mL. Where serum concentrations were below this value, a serum concentration of 9.770 μg/mL was imputed. |
| Time Frame | Baseline (Day 1 [predose]) and Day 240 |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK population included all participants in the as-treated population who received MEDI9314 and who have detectable post-dosing MEDI9314 serum concentrations for accurate estimation of PK parameters. The "Number Analyzed" denotes the number of participants evaluated for this outcome measure. |
| Arm/Group Title | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 | Cohort 6 |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1. | Participants received a single SC injection of MEDI9314 150 mg on Day 1. | Participants received a single SC injection of MEDI9314 300 mg on Day 1. | Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1 | Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose. | Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. |
| Measure Participants | 4 | 4 | 6 | 6 | 6 | 6 |
| Baseline |
21.495
(14.790)
|
9.770
(0.000)
|
22.577
(31.370)
|
9.770
(0.000)
|
9.770
(0.000)
|
9.770
(0.000)
|
| Day 240 |
23.432
(20.738)
|
9.770
(0.000)
|
9.770
(0.000)
|
13.167
(8.320)
|
9.770
(0.000)
|
14.573
(11.766)
|
| Title | Number of Participants Positive for Anti-Drug Antibodies to MEDI9314 |
|---|---|
| Description | Blood samples for immunogenicity assessment included the determination of anti-drug antibodies (ADA) for MEDI9314. The number of participants with positive serum antibodies to MEDI9314 were presented. |
| Time Frame | Baseline (Day 1 [predose]) and Day 240 |
Outcome Measure Data
| Analysis Population Description |
|---|
| As-treated population included participants who received any study drug and summarized according to the treatment they actually received. |
| Arm/Group Title | Placebo | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 | Cohort 6 |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1. | Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1. | Participants received a single SC injection of MEDI9314 150 mg on Day 1. | Participants received a single SC injection of MEDI9314 300 mg on Day 1. | Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1 | Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose. | Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. |
| Measure Participants | 12 | 4 | 4 | 6 | 6 | 6 | 6 |
| Baseline ADA positive |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
16.7%
|
0
0%
|
| Day 240- ADA positive |
0
0%
|
0
0%
|
0
0%
|
2
33.3%
|
1
16.7%
|
1
16.7%
|
1
16.7%
|
Adverse Events
| Time Frame | From the start of study drug administration upto Day 240 | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||||
| Arm/Group Title | Placebo | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 | Cohort 6 | |||||||
| Arm/Group Description | Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1. | Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1. | Participants received a single SC injection of MEDI9314 150 mg on Day 1. | Participants received a single SC injection of MEDI9314 300 mg on Day 1. | Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1 | Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose. | Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. | |||||||
All Cause Mortality |
||||||||||||||
| Placebo | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 | Cohort 6 | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||
Serious Adverse Events |
||||||||||||||
| Placebo | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 | Cohort 6 | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/12 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||
| Placebo | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 | Cohort 6 | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 8/12 (66.7%) | 4/4 (100%) | 2/4 (50%) | 5/6 (83.3%) | 4/6 (66.7%) | 5/6 (83.3%) | 5/6 (83.3%) | |||||||
| Ear and labyrinth disorders | ||||||||||||||
| Ear pain | 0/12 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
| Gastrointestinal disorders | ||||||||||||||
| Diarrhoea | 1/12 (8.3%) | 1 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Dry mouth | 0/12 (0%) | 0 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Nausea | 0/12 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Toothache | 1/12 (8.3%) | 1 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
| Vomiting | 0/12 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| General disorders | ||||||||||||||
| Influenza like illness | 1/12 (8.3%) | 1 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Infusion site bruising | 0/12 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Infusion site erythema | 0/12 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Infusion site pruritus | 0/12 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Injection site bruising | 1/12 (8.3%) | 1 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Injection site erythema | 2/12 (16.7%) | 2 | 4/4 (100%) | 4 | 1/4 (25%) | 1 | 5/6 (83.3%) | 5 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Injection site haemorrhage | 1/12 (8.3%) | 1 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Injection site induration | 0/12 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 4/6 (66.7%) | 4 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Injection site pain | 0/12 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Injection site pruritus | 0/12 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Injection site warmth | 1/12 (8.3%) | 1 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Pyrexia | 0/12 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Immune system disorders | ||||||||||||||
| Seasonal allergy | 0/12 (0%) | 0 | 1/4 (25%) | 1 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Infections and infestations | ||||||||||||||
| Bronchitis | 0/12 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Hordeolum | 0/12 (0%) | 0 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Influenza | 0/12 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Skin bacterial infection | 0/12 (0%) | 0 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Upper respiratory tract infection | 0/12 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Viral upper respiratory tract infection | 3/12 (25%) | 3 | 2/4 (50%) | 2 | 0/4 (0%) | 0 | 2/6 (33.3%) | 2 | 0/6 (0%) | 0 | 3/6 (50%) | 4 | 3/6 (50%) | 5 |
| Injury, poisoning and procedural complications | ||||||||||||||
| Hand fracture | 0/12 (0%) | 0 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Joint dislocation | 0/12 (0%) | 0 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Scratch | 0/12 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Investigations | ||||||||||||||
| Liver function test increased | 0/12 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Transaminases increased | 1/12 (8.3%) | 1 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||||||
| Arthralgia | 0/12 (0%) | 0 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Back pain | 1/12 (8.3%) | 1 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Myalgia intercostal | 0/12 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Nervous system disorders | ||||||||||||||
| Headache | 1/12 (8.3%) | 1 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 1/6 (16.7%) | 2 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
| Psychiatric disorders | ||||||||||||||
| Insomnia | 0/12 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
| Skin and subcutaneous tissue disorders | ||||||||||||||
| Alopecia | 0/12 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
| Dermatitis contact | 0/12 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Miliaria | 0/12 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
| Pruritus | 0/12 (0%) | 0 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises on-going studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
Results Point of Contact
| Name/Title | Rene van der Merwe |
|---|---|
| Organization | MedImmune |
| Phone | +44 (0)1223 898263 |
| information.center@astrazeneca.com |
Responsible Party:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT02669667
Other Study ID Numbers:
- D4361C00002
First Posted:
Feb 1, 2016
Last Update Posted:
Jun 4, 2019
Last Verified:
May 1, 2019