Study to Assess the Safety, Tolerability and PK/PD After 4 Weekly SC Injections of PB1046 in Subjects With Stable HFrEF
Sponsor
PhaseBio Pharmaceuticals Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02808585
Collaborator
(none)
29
5
5
18.2
5.8
0.3
Study Details
Study Description
Brief Summary
This study will be a sequential multiple-dose escalation study that will enroll (randomize and dose) approximately 28 subjects in four cohorts consisting of 3 active and 1 placebo in Cohort 1 and 6 active and 2 placebo in subsequent cohorts. Randomized subjects will receive a fixed weekly dose of study drug or placebo for a 4 week dosing period.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
Qualifying subjects will have a diagnosis of NYHA Class II or III heart failure with a reduced ejection fraction (HFrEF), be in stable condition, and be taking clinician-directed appropriate pharmacological therapy (e.g., angiotensin converting enzyme inhibitors, angiotensin receptor blockers or an evidence based beta blocker) for heart failure at stable doses (with the exception of diuretics) for at least 1 month prior to screening.
During the period between screening and randomization (planned first dose), the study subject will remain on stable pharmacological therapy for heart failure. Also the study subject will be in stable health with no hospitalizations or clinically significant acute illnesses between screening and randomization that would put the subject at increased risk for study participation.
Randomized subjects will receive a fixed weekly dose of study drug or placebo for a 4 week dosing period. Dose escalation in subsequent cohorts will continue if the safety and pharmacokinetic profile are deemed acceptable as assessed by the Study Review Committee.
Study Design
Study Type:
Interventional
Actual Enrollment
:
29 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Randomized, Double-blind, Placebo-controlled, Multiple-Dose, Study to Assess the Safety, Tolerability, PK and PD After 4 Weeks of Once Weekly Sc. Inj. of PB1046 in Adults With Stable HFrEF, and in Subjects With Cardiac Dysfunction Secondary to DMD
Actual Study Start Date
:
Jun 1, 2016
Actual Primary Completion Date
:
Dec 6, 2017
Actual Study Completion Date
:
Dec 6, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PB1046 Injection, 0.2 mg/kg Four weekly doses of PB1046 Injection, 0.2 mg/kg |
Drug: PB1046 Injection
Four weekly subcutaneous injections of PB1046.
Other Names:
|
| Experimental: PB1046 Injection, 0.4 mg/kg Four weekly doses of PB1046 Injection, 0.4 mg/kg |
Drug: PB1046 Injection
Four weekly subcutaneous injections of PB1046.
Other Names:
|
| Experimental: PB1046 Injection, 0.6 mg/kg Four weekly doses of PB1046 Injection, 0.6 mg/kg |
Drug: PB1046 Injection
Four weekly subcutaneous injections of PB1046.
Other Names:
|
| Experimental: PB1046 Injection, 1.2 mg/kg Four weekly doses of PB1046 Injection, 1.2 mg/kg |
Drug: PB1046 Injection
Four weekly subcutaneous injections of PB1046.
Other Names:
|
| Placebo Comparator: Placebo Comparator Four weekly doses of Placebo (0.9% NaCl) Injection |
Drug: Placebo Injection
Four weekly subcutaneous injections of placebo.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Telemetry [Up to six weeks starting 7 to 10 days before first dose.]
Number of participants with rhythm abnormalities as assessed by continuous mobile telemetry monitoring.
- 12-Lead ECG Assessment - Incidence of Clinically Significant Findings [Seven weeks starting the first week of dosing.]
Number of participants with a clinically significant change from baseline in 12-Lead ECG and presence of rhythm abnormalities and relationship to exposure of PB1046 compared to placebo
- 12-Lead ECG - Categorical Analysis of QT/QTc Interval - Participants With Clinically Significant Findings [Seven weeks starting the first week of dosing.]
Number of participants with a clinically significant change from baseline in 12-Lead ECG and presence or absence of rhythm abnormalities and relationship to exposure of PB1046 compared to placebo
- Laboratory Parameters - Serum Chemistry - Participants With Clinically Significant Findings [Eight weeks starting one week before first dose.]
Number of participants with clinically significant changes from baseline in laboratory parameters (serum chemistry) and the relationship to PB1046 compared to placebo
- Laboratory Parameters - Hematology - Participants With Clinically Significant Findings [Eight weeks starting one week before first dose.]
Number of participants with clinically significant changes from baseline in laboratory parameters (hematology) and the relationship to PB1046 compared to placebo
- Laboratory Parameters - Urinalysis - Participants With Clinically Significant Findings [Eight weeks starting one week before first dose.]
Number of participants with clinically significant changes from baseline in laboratory parameters (urinalysis) and the relationship to PB1046 compared to placebo
- Laboratory Parameters - eGFR [Baseline, Week 2, 3, 4, 5 and 8.]
Changes from baseline in laboratory parameters (eGFR) and the relationship to PB1046 compared to placebo. Calculated using Chronic Kidney Disease Epidemiology Collaboration Equation (CKD-EPI)
- Laboratory Parameters - Lipid Profile - Participants With Clinically Significant Findings [Eight weeks starting one week before first dose (Baseline and at Week 8).]
Number of participants with clinically significant changes from baseline in laboratory parameters (lipid profile) and the relationship to PB1046 compared to placebo
- Vital Signs - Systolic Blood Pressure [Baseline, Day 0, Day 1, 2, 3, 5, 7, 14, 21, 22, 23, 24, 26, 28, 29, 30, 31, and 49.]
Changes from baseline in vital signs (systolic blood pressure) and the relationship to PB1046 compared to placebo.
- Vital Signs - Heart Rate [Baseline, Day 0, Day 1, 2, 3, 5, 7, 14, 21, 22, 23, 24, 26, 28, 29, 30, 31, and 49.]
Changes from baseline in vital signs (heart rate) and the relationship to PB1046 compared to placebo.
- Vital Signs - Temperature [Baseline, Day 0, Day 1, 2, 3, 5, 7, 14, 21, 22, 23, 24, 26, 28, 29, 30, 31, and 49.]
Changes from baseline in vital signs (temperature) and the relationship to PB1046 compared to placebo.
- Vital Signs - Respiratory Rate [Baseline, Day 0, Day 1, 2, 3, 5, 7, 14, 21, 22, 23, 24, 26, 28, 29, 30, 31, and 49.]
Changes from baseline in vital signs (respiratory rate) and the relationship to PB1046 compared to placebo.
- Vital Signs - Diastolic Blood Pressure [Baseline, Day 0, Day 1, 2, 3, 5, 7, 14, 21, 22, 23, 24, 26, 28, 29, 30, 31, and 49.]
Changes from baseline in vital signs (systolic blood pressure) and the relationship to PB1046 compared to placebo.
Secondary Outcome Measures
- Pharmacokinetic Profile - Area Under the Curve Over the Dosing Interval [AUC(0-t)] [Pre-dose, Day 1 post-dose (1, 3, 24, 48, 72, 120 hours post-dose 1), Day 7, 14, 21 (1, 3, 24, 48, 72, 120 hours post-dose 4), Day 22, 23, 24, 26, 28, 29, 30, and 31.]
Comparison of dose exposures [AUC(0-t)] during once weekly administration of various doses of PB1046
- Pharmacokinetic Profile - Maximum Serum Concentration (Cmax) [Pre-dose, Day 1 post-dose (1, 3, 24, 48, 72, 120 hours post-dose 1), Day 7, 14, 21 (1, 3, 24, 48, 72, 120 hours post-dose 4), Day 22, 23, 24, 26, 28, 29, 30, and 31.]
Comparison of dose exposures (Cmax) during once weekly administration of various doses of PB1046
- Pharmacokinetic Profile - Time to Cmax (Tmax) [Pre-dose, Day 1 post-dose (1, 3, 24, 48, 72, 120 hours post-dose 1), Day 7, 14, 21 (1, 3, 24, 48, 72, 120 hours post-dose 4), Day 22, 23, 24, 26, 28, 29, 30, and 31.]
Comparison of dose exposures (Tmax) during once weekly administration of various doses of PB1046
- Pharmacokinetic Profile - Elimination Rate Constant (Lambda z) [Pre-dose, Day 1 post-dose (1, 3, 24, 48, 72, 120 hours post-dose 1), Day 7, 14, 21 (1, 3, 24, 48, 72, 120 hours post-dose 4), Day 22, 23, 24, 26, 28, 29, 30, and 31.]
Comparison of dose exposures (lambda z) during once weekly administration of various doses of PB1046
- Pharmacokinetic Profile - Elimination Half-life (t½) [Pre-dose, Day 1 post-dose (1, 3, 24, 48, 72, 120 hours post-dose 1), Day 7, 14, 21 (1, 3, 24, 48, 72, 120 hours post-dose 4), Day 22, 23, 24, 26, 28, 29, 30, and 31.]
Comparison of dose exposures (t½) during once weekly administration of various doses of PB1046
- Pharmacokinetic Profile - Clearance (CL/F), Uncorrected for Bioavailability [Pre-dose, Day 1 post-dose (1, 3, 24, 48, 72, 120 hours post-dose 1), Day 7, 14, 21 (1, 3, 24, 48, 72, 120 hours post-dose 4), Day 22, 23, 24, 26, 28, 29, 30, and 31.]
Comparison of dose exposures (CL/F) during once weekly administration of various doses of PB1046
- Pharmacokinetic Profile - Volume of Distribution (Vz/F), Uncorrected for Bioavailability (F) [Pre-dose, Day 1 post-dose (1, 3, 24, 48, 72, 120 hours post-dose 1), Day 7, 14, 21 (1, 3, 24, 48, 72, 120 hours post-dose 4), Day 22, 23, 24, 26, 28, 29, 30, and 31.]
Comparison of dose exposures (Vz/F) during once weekly administration of various doses of PB1046
- Immunogenicity [Eleven weeks starting the first week of dosing.]
Number of participants reporting positive immunogenicity (four-fold increase of pre-dose titer)
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Willing and able to sign a written informed consent and follow all study-related procedures,
-
Male subjects and female subjects of reproductive or childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study drug,
-
Body mass index ≥ 18 kg/m2 and ≤ 45 kg/m2,
-
Receipt of stable pharmacological therapy(ies) for heart failure for a minimum of 1 month prior to screening and between screening and randomization and are in stable clinical condition,
-
NYHA Class II or III heart failure diagnosis (ischemic or non-ischemic confirmed by medical history) at least 6 months prior to screening,
-
Stable HF defined as no hospitalizations for cardiac related issues within the previous 3 months prior to the screening visit or between screening and randomization,
-
A screening or historical Left Ventricular Ejection Fraction ≤ 40% by centralized reading of 2-D echocardiography,
-
Screening hemoglobin ≥ 9.0 g/dL secondary to the volume of blood to be collected during the study period,
-
Willing and able to return to the study unit for specified study visits, and be able to self-monitor blood pressure while at home,
-
Live and work in an area with reliable cellular services (e.g., Sprint®) for real time transmission of telemetry data to the core laboratory.
Exclusion Criteria:
-
Have previously received PB1046 or have a known allergy to the study drug or any of its components,
-
Participating in any other study and have received any other investigational medication or device within 30 days prior to screening or are taking part in a non-medication study which, in the opinion of the Investigator, would interfere with study compliance or outcome assessments,
-
Diagnosed with acute coronary syndrome (ACS) or an acute myocardial infarction (MI) within 3 months of screening,
-
Canadian Cardiovascular Society (CCS) Class III or IV angina necessitating frequent use of as needed short acting nitroglycerin,
-
Cardiac surgery or valvuloplasty within 3 months prior to screening,
-
Cerebrovascular accident or transient ischemic attack within 3 months prior to screening,
-
Sustained systolic blood pressure (SBP) < 110 mmHg and/or diastolic blood pressure (DBP) < 50 mmHg (confirmed by a duplicate seated reading) on at least 3 consecutive readings (self-monitored or office) prior to randomization or overt symptomatic hypotension,
-
Sustained resting heart rate >100 beats per minute (BPM) at screening (V1) or prior to randomization,
-
History or evidence of clinically significant arrhythmias (uncontrolled by drug therapy or use of an implantable defibrillator), long QT syndrome or evidence of QT prolongation demonstrating QTcF > 460 ms prior to randomization (Subjects with QTcF
460 ms due to electronic pacing by an implanted pacemaker/ICD device may be enrolled),
-
Clinically significant renal dysfunction as measured by the estimated glomerular filtration rate (eGFR) of < 40 mL/min/1.73m2 as calculated by the CKD-EPI creatinine-cystatin C equation at screening, or a clinically significant change in renal function between screening and baseline,
-
Clinically significant liver dysfunction as measured by: alanine aminotransferase >3.0 × the upper limit of normal (ULN), aspartate aminotransferase >3.0 × the ULN, or serum bilirubin ≥ 1.6 mg/dL at screening, or a clinically significant change in liver function between screening and baseline,
-
Pregnant or lactating female subjects,
-
Known history of or active alcohol abuse or use of illicit drugs within 1 year prior to randomization,
-
Positive screening for human immunodeficiency virus antibodies, hepatitis B surface antigen, or hepatitis C virus antibodies,
-
Any major surgical procedure within 1 month prior to screening or planned surgical procedure during the study period,
-
Other medical or psychiatric condition which, in the opinion of the Investigator, would place the subject at increased risk or would preclude obtaining voluntary consent/assent or would confound the secondary objectives of study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pinnacle Research Group, LLC | Anniston | Alabama | United States | 36207 |
| 2 | Phoenix Medical Research | Peoria | Arizona | United States | 85381 |
| 3 | Cardiology Associates Research Company | Daytona Beach | Florida | United States | 32117 |
| 4 | Revivial Research | Miami | Florida | United States | 33173 |
| 5 | North Dallas Research Associates | McKinney | Texas | United States | 75069 |
Sponsors and Collaborators
- PhaseBio Pharmaceuticals Inc.
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
PhaseBio Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT02808585
Other Study ID Numbers:
- PB1046-PT-CL-0003-P1
First Posted:
Jun 22, 2016
Last Update Posted:
Jul 14, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | PB1046 Injection, 0.2 mg/kg | PB1046 Injection, 0.4 mg/kg | PB1046 Injection, 0.6 mg/kg | PB1046 Injection, 1.2 mg/kg | Placebo Comparator |
|---|---|---|---|---|---|
| Arm/Group Description | Four weekly doses of PB1046 Injection, 0.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.4 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.6 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 1.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of Placebo (0.9% NaCl) Injection Placebo Injection: Four weekly subcutaneous injections of placebo. |
| Period Title: Overall Study | |||||
| STARTED | 3 | 6 | 7 | 6 | 7 |
| COMPLETED | 3 | 6 | 6 | 4 | 7 |
| NOT COMPLETED | 0 | 0 | 1 | 2 | 0 |
Baseline Characteristics
| Arm/Group Title | PB1046 Injection, 0.2 mg/kg | PB1046 Injection, 0.4 mg/kg | PB1046 Injection, 0.6 mg/kg | PB1046 Injection, 1.2 mg/kg | Placebo Comparator | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | Four weekly doses of PB1046 Injection, 0.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.4 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.6 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 1.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of Placebo (0.9% NaCl) Injection Placebo Injection: Four weekly subcutaneous injections of placebo. | Total of all reporting groups |
| Overall Participants | 3 | 6 | 7 | 6 | 7 | 29 |
| Age (years) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [years] |
60.7
(13.01)
|
69.7
(10.89)
|
67.6
(11.27)
|
64.3
(4.03)
|
65
(8.41)
|
66.0
(9.18)
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
2
66.7%
|
0
0%
|
3
42.9%
|
2
33.3%
|
1
14.3%
|
8
27.6%
|
| Male |
1
33.3%
|
6
100%
|
4
57.1%
|
4
66.7%
|
6
85.7%
|
21
72.4%
|
| Race (NIH/OMB) (Count of Participants) | ||||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
1
16.7%
|
0
0%
|
0
0%
|
0
0%
|
1
3.4%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
1
33.3%
|
0
0%
|
1
14.3%
|
0
0%
|
1
14.3%
|
3
10.3%
|
| White |
2
66.7%
|
5
83.3%
|
6
85.7%
|
6
100%
|
6
85.7%
|
25
86.2%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | ||||||
| United States |
3
100%
|
6
100%
|
7
100%
|
6
100%
|
7
100%
|
29
100%
|
Outcome Measures
| Title | Telemetry |
|---|---|
| Description | Number of participants with rhythm abnormalities as assessed by continuous mobile telemetry monitoring. |
| Time Frame | Up to six weeks starting 7 to 10 days before first dose. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety/Intent-to-Treat/Per Protocol Population |
| Arm/Group Title | PB1046 Injection, 0.2 mg/kg | PB1046 Injection, 0.4 mg/kg | PB1046 Injection, 0.6 mg/kg | PB1046 Injection, 1.2 mg/kg | Placebo Comparator |
|---|---|---|---|---|---|
| Arm/Group Description | Four weekly doses of PB1046 Injection, 0.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.4 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.6 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 1.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of Placebo (0.9% NaCl) Injection Placebo Injection: Four weekly subcutaneous injections of placebo. |
| Measure Participants | 3 | 6 | 6 | 4 | 7 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | 12-Lead ECG Assessment - Incidence of Clinically Significant Findings |
|---|---|
| Description | Number of participants with a clinically significant change from baseline in 12-Lead ECG and presence of rhythm abnormalities and relationship to exposure of PB1046 compared to placebo |
| Time Frame | Seven weeks starting the first week of dosing. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety/Intent-to-Treat/Per Protocol Population |
| Arm/Group Title | PB1046 Injection, 0.2 mg/kg | PB1046 Injection, 0.4 mg/kg | PB1046 Injection, 0.6 mg/kg | PB1046 Injection, 1.2 mg/kg | Placebo Comparator |
|---|---|---|---|---|---|
| Arm/Group Description | Four weekly doses of PB1046 Injection, 0.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.4 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.6 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 1.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of placebo comparator, 0.9% NaCl. PB1046 Injection: Four weekly subcutaneous injections of placebo comparator. |
| Measure Participants | 3 | 6 | 7 | 6 | 7 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | 12-Lead ECG - Categorical Analysis of QT/QTc Interval - Participants With Clinically Significant Findings |
|---|---|
| Description | Number of participants with a clinically significant change from baseline in 12-Lead ECG and presence or absence of rhythm abnormalities and relationship to exposure of PB1046 compared to placebo |
| Time Frame | Seven weeks starting the first week of dosing. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety/Intent-to-Treat/Per Protocol Population |
| Arm/Group Title | PB1046 Injection, 0.2 mg/kg | PB1046 Injection, 0.4 mg/kg | PB1046 Injection, 0.6 mg/kg | PB1046 Injection, 1.2 mg/kg | Placebo Comparator |
|---|---|---|---|---|---|
| Arm/Group Description | Four weekly doses of PB1046 Injection, 0.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.4 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.6 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 1.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of placebo comparator, 0.9% NaCl. PB1046 Injection: Four weekly subcutaneous injections of placebo comparator. |
| Measure Participants | 3 | 6 | 7 | 6 | 7 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Laboratory Parameters - Serum Chemistry - Participants With Clinically Significant Findings |
|---|---|
| Description | Number of participants with clinically significant changes from baseline in laboratory parameters (serum chemistry) and the relationship to PB1046 compared to placebo |
| Time Frame | Eight weeks starting one week before first dose. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety/Intent-to-Treat/Per Protocol Population |
| Arm/Group Title | PB1046 Injection, 0.2 mg/kg | PB1046 Injection, 0.4 mg/kg | PB1046 Injection, 0.6 mg/kg | PB1046 Injection, 1.2 mg/kg | Placebo Comparator |
|---|---|---|---|---|---|
| Arm/Group Description | Four weekly doses of PB1046 Injection, 0.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.4 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.6 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 1.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of placebo comparator, 0.9% NaCl. PB1046 Injection: Four weekly subcutaneous injections of placebo comparator. |
| Measure Participants | 3 | 6 | 7 | 6 | 7 |
| Count of Participants [Participants] |
0
0%
|
1
16.7%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Laboratory Parameters - Hematology - Participants With Clinically Significant Findings |
|---|---|
| Description | Number of participants with clinically significant changes from baseline in laboratory parameters (hematology) and the relationship to PB1046 compared to placebo |
| Time Frame | Eight weeks starting one week before first dose. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety/Intent-to-Treat/Per Protocol Population |
| Arm/Group Title | PB1046 Injection, 0.2 mg/kg | PB1046 Injection, 0.4 mg/kg | PB1046 Injection, 0.6 mg/kg | PB1046 Injection, 1.2 mg/kg | Placebo Comparator |
|---|---|---|---|---|---|
| Arm/Group Description | Four weekly doses of PB1046 Injection, 0.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.4 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.6 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 1.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of placebo comparator. |
| Measure Participants | 3 | 6 | 7 | 6 | 7 |
| Count of Participants [Participants] |
1
33.3%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Laboratory Parameters - Urinalysis - Participants With Clinically Significant Findings |
|---|---|
| Description | Number of participants with clinically significant changes from baseline in laboratory parameters (urinalysis) and the relationship to PB1046 compared to placebo |
| Time Frame | Eight weeks starting one week before first dose. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety/Intent-to-Treat/Per Protocol Population |
| Arm/Group Title | PB1046 Injection, 0.2 mg/kg | PB1046 Injection, 0.4 mg/kg | PB1046 Injection, 0.6 mg/kg | PB1046 Injection, 1.2 mg/kg | Placebo Comparator |
|---|---|---|---|---|---|
| Arm/Group Description | Four weekly doses of PB1046 Injection, 0.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.4 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.6 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 1.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of placebo comparator, 0.9% NaCl. PB1046 Injection: Four weekly subcutaneous injections of placebo comparator. |
| Measure Participants | 3 | 6 | 7 | 6 | 7 |
| Count of Participants [Participants] |
0
0%
|
2
33.3%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Laboratory Parameters - eGFR |
|---|---|
| Description | Changes from baseline in laboratory parameters (eGFR) and the relationship to PB1046 compared to placebo. Calculated using Chronic Kidney Disease Epidemiology Collaboration Equation (CKD-EPI) |
| Time Frame | Baseline, Week 2, 3, 4, 5 and 8. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety/Intent-to-Treat/Per Protocol Population. One subject at 0.6 mg/kg dose missed sample collection and was excluded from analysis. |
| Arm/Group Title | PB1046 Injection, 0.2 mg/kg | PB1046 Injection, 0.4 mg/kg | PB1046 Injection, 0.6 mg/kg | PB1046 Injection, 1.2 mg/kg | Placebo Comparator |
|---|---|---|---|---|---|
| Arm/Group Description | Four weekly doses of PB1046 Injection, 0.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.4 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.6 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 1.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of Placebo (0.9% NaCl) Injection Placebo Injection: Four weekly subcutaneous injections of placebo. |
| Measure Participants | 3 | 6 | 6 | 6 | 7 |
| Week 2 |
-1.04
(4.00)
|
2.2
(11.41)
|
-2.9
(13.23)
|
1.3
(7.39)
|
-4.6
(5.88)
|
| Week 3 |
-0.3
(5.77)
|
0.2
(10.72)
|
2.3
(11.40)
|
1.8
(7.57)
|
-4.6
(5.19)
|
| Week 4 |
0.0
(2.65)
|
-1.3
(7.97)
|
-1.4
(4.12)
|
5.8
(9.55)
|
-6.6
(6.13)
|
| Week 5 |
-0.3
(6.66)
|
-0.7
(7.26)
|
-2.2
(13.29)
|
9.3
(7.93)
|
-2.3
(6.63)
|
| Week 8 |
-3.3
(8.62)
|
-5.7
(11.41)
|
-3.7
(14.22)
|
-0.2
(6.79)
|
-3.0
(4.12)
|
| Title | Laboratory Parameters - Lipid Profile - Participants With Clinically Significant Findings |
|---|---|
| Description | Number of participants with clinically significant changes from baseline in laboratory parameters (lipid profile) and the relationship to PB1046 compared to placebo |
| Time Frame | Eight weeks starting one week before first dose (Baseline and at Week 8). |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | PB1046 Injection, 0.2 mg/kg | PB1046 Injection, 0.4 mg/kg | PB1046 Injection, 0.6 mg/kg | PB1046 Injection, 1.2 mg/kg | Placebo Comparator |
|---|---|---|---|---|---|
| Arm/Group Description | Four weekly doses of PB1046 Injection, 0.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.4 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.6 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 1.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of placebo comparator, 0.9% NaCl. PB1046 Injection: Four weekly subcutaneous injections of placebo comparator. |
| Measure Participants | 3 | 6 | 7 | 6 | 7 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Vital Signs - Systolic Blood Pressure |
|---|---|
| Description | Changes from baseline in vital signs (systolic blood pressure) and the relationship to PB1046 compared to placebo. |
| Time Frame | Baseline, Day 0, Day 1, 2, 3, 5, 7, 14, 21, 22, 23, 24, 26, 28, 29, 30, 31, and 49. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety/Intent-to-Treat/Per Protocol Population |
| Arm/Group Title | PB1046 Injection, 0.2 mg/kg | PB1046 Injection, 0.4 mg/kg | PB1046 Injection, 0.6 mg/kg | PB1046 Injection, 1.2 mg/kg | Placebo Comparator |
|---|---|---|---|---|---|
| Arm/Group Description | Four weekly doses of PB1046 Injection, 0.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.4 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.6 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 1.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of Placebo (0.9% NaCl) Injection Placebo Injection: Four weekly subcutaneous injections of placebo. |
| Measure Participants | 3 | 6 | 6 | 4 | 7 |
| Day 0 1 hr |
7.4
(10.88)
|
-6.2
(19.89)
|
3.1
(8.17)
|
-2.6
(13.43)
|
4.6
(17.41)
|
| Day 0 3 hr |
4.9
(7.17)
|
-2.6
(14.06)
|
1.3
(6.52)
|
-8.7
(6.24)
|
3.4
(11.57)
|
| Day 1 |
-3.4
(2.87)
|
-5.8
(14.89)
|
-2.3
(4.79)
|
-15.4
(18.17)
|
-7.1
(14.59)
|
| Day 2 |
-0.6
(7.07)
|
-4.4
(13.45)
|
-7.2
(7.98)
|
-8.9
(12.63)
|
-2.9
(23.54)
|
| Day 3 |
-6.7
(8.25)
|
1.8
(24.86)
|
-8.9
(9.08)
|
-17.8
(18.09)
|
-1.8
(16.75)
|
| Day 5 |
2.4
(11.42)
|
-4.6
(23.37)
|
1.5
(8.57)
|
-11.7
(20.19)
|
1.3
(10.44)
|
| Day 7 pre |
-6.9
(2.22)
|
-9.4
(11.47)
|
-5.9
(13.47)
|
-11.7
(3.78)
|
-0.3
(10.73)
|
| Day 14 pre |
4.3
(9.60)
|
-8.0
(14.73)
|
-1.6
(9.32)
|
-8.8
(14.62)
|
-3.0
(17.71)
|
| Day 21 pre |
-3.0
(6.57)
|
-8.4
(9.37)
|
-1.6
(9.32)
|
-8.8
(14.62)
|
-5.1
(13.04)
|
| Day 21 1 hr |
-7.9
(4.40)
|
-14.1
(9.15)
|
-4.0
(10.00)
|
-12.8
(15.89)
|
-3.0
(9.00)
|
| Day 21 3 hr |
-7.9
(4.40)
|
-14.1
(9.15)
|
-4.0
(10.00)
|
-12.8
(15.89)
|
-3.0
(9.00)
|
| Day 22 |
-5.0
(4.81)
|
-10.6
(18.27)
|
-9.4
(10.46)
|
-20.8
(17.19)
|
-3.4
(13.67)
|
| Day 23 |
-9.2
(12.16)
|
-4.7
(9.18)
|
-9.2
(11.77)
|
-8.0
(4.33)
|
-0.8
(11.38)
|
| Day 24 |
0.9
(5.50)
|
-1.9
(9.19)
|
-1.0
(12.16)
|
-21.6
(29.51)
|
2.0
(20.23)
|
| Day 26 |
-8.7
(8.02)
|
-11.6
(8.41)
|
-11.4
(5.05)
|
-9.6
(19.51)
|
-4.5
(14.75)
|
| Day 28 |
2.1
(9.83)
|
-9.4
(13.93)
|
-8.1
(12.89)
|
-6.3
(20.28)
|
-1.2
(21.19)
|
| Day 29 |
4.2
(12.05)
|
-7.4
(15.88)
|
-4.6
(12.30)
|
-8.9
(7.54)
|
-3.6
(21.02)
|
| Day 30 |
0.8
(8.00)
|
-7.6
(18.85)
|
-5.9
(9.96)
|
-11.0
(15.48)
|
-4.5
(25.36)
|
| Day 31 |
-3.4
(1.35)
|
-10.4
(17.18)
|
-9.3
(9.45)
|
-12.8
(14.83)
|
-0.2
(13.98)
|
| Day 49 |
7.1
(14.95)
|
-6.9
(12.42)
|
-10.2
(11.97)
|
-16.8
(22.45)
|
-3.0
(14.78)
|
| Title | Vital Signs - Heart Rate |
|---|---|
| Description | Changes from baseline in vital signs (heart rate) and the relationship to PB1046 compared to placebo. |
| Time Frame | Baseline, Day 0, Day 1, 2, 3, 5, 7, 14, 21, 22, 23, 24, 26, 28, 29, 30, 31, and 49. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety/Intent-to-Treat/Per Protocol Population |
| Arm/Group Title | PB1046 Injection, 0.2 mg/kg | PB1046 Injection, 0.4 mg/kg | PB1046 Injection, 0.6 mg/kg | PB1046 Injection, 1.2 mg/kg | Placebo Comparator |
|---|---|---|---|---|---|
| Arm/Group Description | Four weekly doses of PB1046 Injection, 0.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.4 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.6 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 1.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of Placebo (0.9% NaCl) Injection Placebo Injection: Four weekly subcutaneous injections of placebo. |
| Measure Participants | 3 | 6 | 6 | 4 | 7 |
| Day 0 1 hr |
-1.8
(4.55)
|
-2.1
(6.23)
|
-2.5
(9.66)
|
2.3
(3.64)
|
-3.0
(5.79)
|
| Day 0 3 hr |
2.7
(6.49)
|
-2.4
(5.39)
|
0.0
(8.67)
|
1.2
(2.83)
|
3.0
(9.64)
|
| Day 1 |
-0.7
(1.15)
|
4.1
(3.38)
|
-1.6
(9.66)
|
4.1
(5.53)
|
3.2
(4.09)
|
| Day 2 |
1.7
(2.31)
|
-6.0
(15.58)
|
-3.3
(8.73)
|
2.6
(3.83)
|
4.5
(8.66)
|
| Day 3 |
3.8
(1.35)
|
-0.8
(5.51)
|
-2.2
(4.24)
|
1.4
(5.86)
|
-.04
(6.82)
|
| Day 5 |
-1.2
(3.67)
|
-2.9
(5.06)
|
-3.2
(9.09)
|
2.9
(5.85)
|
3.1
(8.62)
|
| Day 7 pre |
0.6
(2.67)
|
-0.4
(5.74)
|
-4.5
(6.05)
|
1.6
(1.83)
|
-1.7
(8.01)
|
| Day 14 pre |
-2.4
(2.14)
|
-3.7
(6.26)
|
-0.6
(2.65)
|
0.5
(1.29)
|
-1.9
(7.16)
|
| Day 21 pre |
3.6
(4.67)
|
-2.6
(7.62)
|
-2.7
(2.72)
|
0.2
(0.96)
|
-4.7
(5.84)
|
| Day 21 1 hr |
3.6
(4.67)
|
-1.4
(7.49)
|
0.9
(2.23)
|
1.2
(1.00)
|
-4.7
(5.84)
|
| Day 21 3 hr |
8.3
(4.93)
|
3.6
(3.62)
|
-0.9
(3.51)
|
0.9
(1.83)
|
0.2
(10.92)
|
| Day 22 |
2.2
(3.02)
|
-3.3
(10.02)
|
0.3
(5.37)
|
0.4
(1.07)
|
0.3
(8.10)
|
| Day 23 |
-1.8
(1.68)
|
-2.4
(13.10)
|
-2.5
(5.92)
|
1.4
(1.32)
|
-0.9
(10.13)
|
| Day 24 |
-2.4
(3.15)
|
-0.8
(8.52)
|
-2.1
(4.65)
|
1.4
(1.40)
|
-1.5
(7.49)
|
| Day 26 |
1.4
(3.91)
|
-2.2
(10.56)
|
-1.6
(6.97)
|
0.4
(1.13)
|
-0.8
(7.77)
|
| Day 28 |
-2.0
(8.09)
|
-0.5
(11.09)
|
-1.5
(2.10)
|
0.2
(1.97)
|
-2.8
(7.52)
|
| Day 29 |
0.3
(3.18)
|
-2.5
(8.62)
|
-2.1
(9.99)
|
2.9
(7.47)
|
-1.1
(6.84)
|
| Day 30 |
-2.4
(2.50)
|
-3.9
(11.54)
|
-3.6
(7.61)
|
0.8
(1.67)
|
1.7
(8.13)
|
| Day 31 |
-3.4
(3.10)
|
-4.9
(8.27)
|
-1.4
(4.96)
|
-1.6
(1.95)
|
0.5
(7.43)
|
| Day 49 |
-2.0
(2.33)
|
-2.9
(14.19)
|
-2.3
(4.67)
|
1.8
(4.84)
|
-2.4
(5.70)
|
| Title | Vital Signs - Temperature |
|---|---|
| Description | Changes from baseline in vital signs (temperature) and the relationship to PB1046 compared to placebo. |
| Time Frame | Baseline, Day 0, Day 1, 2, 3, 5, 7, 14, 21, 22, 23, 24, 26, 28, 29, 30, 31, and 49. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety/Intent-to-Treat/Per Protocol Population |
| Arm/Group Title | PB1046 Injection, 0.2 mg/kg | PB1046 Injection, 0.4 mg/kg | PB1046 Injection, 0.6 mg/kg | PB1046 Injection, 1.2 mg/kg | Placebo Comparator |
|---|---|---|---|---|---|
| Arm/Group Description | Four weekly doses of PB1046 Injection, 0.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.4 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.6 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 1.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of Placebo (0.9% NaCl) Injection Placebo Injection: Four weekly subcutaneous injections of placebo. |
| Measure Participants | 3 | 6 | 6 | 4 | 7 |
| Day 0 1 hr |
0.0
(0.10)
|
-0.1
(0.35)
|
0.0
(0.34)
|
0.0
(0.33)
|
-0.1
(0.28)
|
| Day 0 3 hr |
-0.1
(0.06)
|
-0.2
(0.36)
|
0.0
(0.39)
|
0.1
(0.24)
|
0.2
(0.53)
|
| Day 1 |
0.1
(0.12)
|
-0.3
(0.52)
|
-0.1
(0.40)
|
0.3
(0.14)
|
0.2
(0.38)
|
| Day 2 |
-1.1
(2.06)
|
-0.5
(0.65)
|
-0.0
(0.45)
|
0.1
(0.23)
|
-0.1
(0.59)
|
| Day 3 |
-1.2
(2.20)
|
-0.2
(0.46)
|
0.0
(0.49)
|
0.1
(0.39)
|
0.0
(0.66)
|
| Day 5 |
0.1
(0.21)
|
-0.2
(0.36)
|
0.1
(0.26)
|
0.1
(0.39)
|
0.0
(0.52)
|
| Day 7 pre |
-0.1
(0.06)
|
0.0
(1.22)
|
0.1
(0.27)
|
0.0
(0.25)
|
0.1
(0.37)
|
| Day 14 pre |
-0.2
(0.49)
|
-0.1
(0.39)
|
0.2
(0.27)
|
0.1
(0.29)
|
0.1
(0.48)
|
| Day 21 1 hr |
0.1
(0.36)
|
0.1
(0.48)
|
0.0
(0.42)
|
0.1
(0.34)
|
0.1
(0.50)
|
| Day 21 3 hr |
0.1
(0.23)
|
-0.2
(0.29)
|
-0.1
(0.39)
|
-0.1
(0.36)
|
0.0
(0.55)
|
| Day 22 |
0.1
(0.31)
|
0.1
(0.24)
|
0.2
(0.24)
|
-0.1
(0.22)
|
0.0
(0.49)
|
| Day 23 |
0.3
(0.25)
|
0.2
(0.25)
|
0.1
(0.23)
|
0.1
(0.26)
|
0.1
(0.48)
|
| Day 24 |
0.3
(0.40)
|
0.1
(0.28)
|
0.2
(0.30)
|
-0.1
(0.51)
|
0.1
(0.47)
|
| Day 26 |
0.2
(0.15)
|
0.0
(0.66)
|
0.1
(0.34)
|
-0.1
(0.15)
|
0.0
(0.44)
|
| Day 28 |
-0.6
(1.42)
|
0.2
(0.53)
|
-0.2
(0.43)
|
0.3
(0.30)
|
0.0
(0.44)
|
| Day 29 |
0.1
(0.21)
|
-0.3
(0.69)
|
0.0
(0.40)
|
0.1
(0.38)
|
0.1
(0.52)
|
| Day 30 |
-1.0
(1.91)
|
-0.1
(0.69)
|
0.1
(0.30)
|
0.0
(0.44)
|
0.1
(0.51)
|
| Day 31 |
0.3
(0.25)
|
0.1
(0.57)
|
0.1
(0.37)
|
-0.2
(0.29)
|
-0.1
(0.73)
|
| Day 49 |
0.1
(0.36)
|
0.1
(0.55)
|
0.1
(0.42)
|
0.0
(0.43)
|
8.7
(22.71)
|
| Title | Vital Signs - Respiratory Rate |
|---|---|
| Description | Changes from baseline in vital signs (respiratory rate) and the relationship to PB1046 compared to placebo. |
| Time Frame | Baseline, Day 0, Day 1, 2, 3, 5, 7, 14, 21, 22, 23, 24, 26, 28, 29, 30, 31, and 49. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety/Intent-to-Treat/Per Protocol Population |
| Arm/Group Title | PB1046 Injection, 0.2 mg/kg | PB1046 Injection, 0.4 mg/kg | PB1046 Injection, 0.6 mg/kg | PB1046 Injection, 1.2 mg/kg | Placebo Comparator |
|---|---|---|---|---|---|
| Arm/Group Description | Four weekly doses of PB1046 Injection, 0.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.4 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.6 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 1.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of Placebo (0.9% NaCl) Injection Placebo Injection: Four weekly subcutaneous injections of placebo. |
| Measure Participants | 3 | 6 | 6 | 4 | 7 |
| Day 0 1 hr |
0.7
(1.15)
|
0.3
(1.51)
|
0.9
(1.57)
|
-0.3
(1.51)
|
0.4
(1.51)
|
| Day 0 3hr |
1.3
(2.31)
|
0.7
(2.07)
|
0.0
(1.15)
|
0.0
(1.26)
|
0.8
(1.83)
|
| Day 1 |
0.7
(1.15)
|
0.3
(2.25)
|
-0.6
(1.51)
|
-1.0
(1.10)
|
0.3
(1.25)
|
| Day 2 |
1.0
(1.00)
|
0.3
(1.77)
|
0.3
(0.76)
|
-0.3
(1.51)
|
-0.1
(1.81)
|
| Day 3 |
0.7
(1.15)
|
-1.2
(2.15)
|
0.3
(2.14)
|
0.3
(1.51)
|
0.1
(1.07)
|
| Day 5 |
0.0
(0.00)
|
0.4
(1.75)
|
-0.1
(0.90)
|
0.3
(0.082)
|
0.6
(1.62)
|
| Day 21 1hr |
-1.3
(1.15)
|
0.7
(2.07)
|
-0.3
(1.51)
|
-0.5
(1.00)
|
-0.4
(3.05)
|
| Day 21 3 hr |
0.0
(2.00)
|
0.0
(0.00)
|
-0.3
(1.97)
|
0.5
(1.00)
|
0.4
(2.44)
|
| Day 21 pre |
-1.3
(1.15)
|
1.0
(3.52)
|
0.7
(1.63)
|
0.0
(0.00)
|
0.6
(1.81)
|
| Day 22 |
0.0
(2.00)
|
1.5
(2.51)
|
0.0
(2.19)
|
-0.5
(1.00)
|
0.2
(2.28)
|
| Day 23 |
0.0
(2.00)
|
0.8
(1.60)
|
-1.0
(2.10)
|
-0.5
(1.00)
|
-0.4
(3.15)
|
| Day 24 |
-0.7
(1.15)
|
1.2
(2.56)
|
0.0
(1.79)
|
-0.5
(1.00)
|
0.2
(1.56)
|
| Day 26 |
-0.7
(1.15)
|
1.2
(2.56)
|
0.0
(1.79)
|
-0.5
(1.00)
|
0.3
(1.89)
|
| Day 28 |
0.0
(2.00)
|
1.2
(3.37)
|
0.3
(1.97)
|
-0.5
(1.00)
|
0.6
(2.44)
|
| Day 29 |
-0.7
(1.15)
|
1.7
(3.44)
|
-0.3
(1.51)
|
-1.0
(1.15)
|
-0.3
(2.06)
|
| Day 30 |
0.7
(1.15)
|
1.3
(2.42)
|
0.0
(1.26)
|
-1.0
(1.15)
|
0.3
(2.43)
|
| Day 49 |
-0.7
(1.15)
|
1.2
(2.40)
|
0.7
(1.03)
|
0.0
(1.26)
|
-0.3
(1.38)
|
| Title | Vital Signs - Diastolic Blood Pressure |
|---|---|
| Description | Changes from baseline in vital signs (systolic blood pressure) and the relationship to PB1046 compared to placebo. |
| Time Frame | Baseline, Day 0, Day 1, 2, 3, 5, 7, 14, 21, 22, 23, 24, 26, 28, 29, 30, 31, and 49. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety/Intent-to-Treat/Per Protocol Population |
| Arm/Group Title | PB1046 Injection, 0.2 mg/kg | PB1046 Injection, 0.4 mg/kg | PB1046 Injection, 0.6 mg/kg | PB1046 Injection, 1.2 mg/kg | Placebo Comparator |
|---|---|---|---|---|---|
| Arm/Group Description | Four weekly doses of PB1046 Injection, 0.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.4 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.6 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 1.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of Placebo (0.9% NaCl) Injection Placebo Injection: Four weekly subcutaneous injections of placebo. |
| Measure Participants | 3 | 6 | 6 | 4 | 7 |
| Day 0 1 hr |
-2.3
(3.38)
|
-5.7
(13.53)
|
-2.5
(10.64)
|
-1.4
(5.68)
|
7.8
(9.34)
|
| Day 0 3 hr |
-0.1
(2.50)
|
-3.1
(11.89)
|
-4.4
(11.10)
|
-3.9
(4.08)
|
2.6
(3.50)
|
| Day 1 |
-2.7
(1.76)
|
-1.9
(9.52)
|
-1.5
(7.77)
|
-9.5
(11.69)
|
3.8
(7.99)
|
| Day 2 |
-0.9
(5.09)
|
-1.7
(7.48)
|
-3.0
(9.41)
|
-5.7
(7.20)
|
3.6
(10.18)
|
| Day 3 |
-5.8
(2.17)
|
0.1
(10.36)
|
-2.0
(8.14)
|
-11.3
(7.33)
|
2.8
(7.93)
|
| Day 5 |
1.1
(7.88)
|
1.3
(9.01)
|
-1.1
(6.61)
|
-6.9
(12.32)
|
1.2
(5.82)
|
| Day 7 pre |
-2.2
(8.60)
|
-2.5
(6.88)
|
-1.4
(12.28)
|
-2.5
(15.60)
|
3.6
(6.05)
|
| Day 14 pre |
3.1
(4.44)
|
-2.9
(7.07)
|
-0.2
(7.73)
|
-4.7
(7.88)
|
6.0
(6.28)
|
| Day 21 pre |
0.7
(2.40)
|
-1.3
(8.50)
|
2.1
(10.83)
|
-5.8
(5.91)
|
4.2
(7.23)
|
| Day 21 1 hr |
-3.4
(1.26)
|
-4.9
(11.98)
|
-2.2
(9.70)
|
-9.8
(6.43)
|
2.2
(8.35)
|
| Day 21 3 hr |
-1.4
(3.91)
|
-7.3
(6.34)
|
-0.9
(10.82)
|
-9.8
(8.03)
|
4.3
(6.82)
|
| Day 22 |
-2.1
(4.40)
|
-6.1
(10.52)
|
-2.2
(9.80)
|
-10.8
(8.63)
|
1.8
(9.89)
|
| Day 23 |
-2.1
(5.00)
|
-2.1
(8.88)
|
-3.2
(12.10)
|
-6.1
(5.39)
|
4.5
(7.81)
|
| Day 24 |
1.0
(2.91)
|
1.3
(7.61)
|
1.7
(9.05)
|
-12.8
(14.55)
|
3.0
(10.50)
|
| Day 26 |
-1.4
(7.13)
|
-6.1
(9.86)
|
-3.2
(10.03)
|
-6.4
(6.58)
|
0.8
(6.74)
|
| Day 28 |
-1.4
(1.58)
|
-1.4
(9.43)
|
-0.2
(8.64)
|
-8.3
(12.66)
|
3.7
(10.41)
|
| Day 29 |
1.6
(7.34)
|
-2.0
(6.72)
|
-1.5
(9.98)
|
-3.7
(9.64)
|
2.9
(6.22)
|
| Day 30 |
2.8
(2.52)
|
-2.8
(7.92)
|
-1.9
(11.77)
|
-8.8
(5.47)
|
3.6
(9.02)
|
| Day 31 |
-4.3
(4.04)
|
-4.6
(10.98)
|
0.3
(10.02)
|
-8.9
(6.10)
|
3.9
(6.99)
|
| Day 49 |
2.6
(2.22)
|
-3.1
(7.86)
|
-5.3
(11.08)
|
-5.0
(10.27)
|
5.1
(4.89)
|
| Title | Pharmacokinetic Profile - Area Under the Curve Over the Dosing Interval [AUC(0-t)] |
|---|---|
| Description | Comparison of dose exposures [AUC(0-t)] during once weekly administration of various doses of PB1046 |
| Time Frame | Pre-dose, Day 1 post-dose (1, 3, 24, 48, 72, 120 hours post-dose 1), Day 7, 14, 21 (1, 3, 24, 48, 72, 120 hours post-dose 4), Day 22, 23, 24, 26, 28, 29, 30, and 31. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety/Intent-to-Treat/Per Protocol Population. Only subjects with sufficient data analyzed. |
| Arm/Group Title | PB1046 Injection, 0.2 mg/kg | PB1046 Injection, 0.4 mg/kg | PB1046 Injection, 0.6 mg/kg | PB1046 Injection, 1.2 mg/kg |
|---|---|---|---|---|
| Arm/Group Description | Four weekly doses of PB1046 Injection, 0.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.4 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.6 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 1.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. |
| Measure Participants | 2 | 6 | 6 | 4 |
| Week 1 |
5791.391
(1639.3)
|
12382.716
(4869.3)
|
14789.912
(4269.7)
|
25555.798
(11248.6)
|
| Week 4 |
7440.721
(6183.8)
|
19007.517
(12655.5)
|
16689.657
(7313.0)
|
21997.727
(7709.6)
|
| Title | Pharmacokinetic Profile - Maximum Serum Concentration (Cmax) |
|---|---|
| Description | Comparison of dose exposures (Cmax) during once weekly administration of various doses of PB1046 |
| Time Frame | Pre-dose, Day 1 post-dose (1, 3, 24, 48, 72, 120 hours post-dose 1), Day 7, 14, 21 (1, 3, 24, 48, 72, 120 hours post-dose 4), Day 22, 23, 24, 26, 28, 29, 30, and 31. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety/Intent-to-Treat/Per Protocol Population. Only subjects with sufficient data analyzed. |
| Arm/Group Title | PB1046 Injection, 0.2 mg/kg | PB1046 Injection, 0.4 mg/kg | PB1046 Injection, 0.6 mg/kg | PB1046 Injection, 1.2 mg/kg |
|---|---|---|---|---|
| Arm/Group Description | Four weekly doses of PB1046 Injection, 0.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.4 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.6 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 1.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. |
| Measure Participants | 3 | 6 | 6 | 4 |
| Week 1 |
47.433
(17.3)
|
128.317
(64.1)
|
218.471
(106.3)
|
207.600
(112.3)
|
| Week 4 |
53.600
(40.2)
|
233.450
(189.6)
|
211.967
(110.1)
|
239.000
(102.6)
|
| Title | Pharmacokinetic Profile - Time to Cmax (Tmax) |
|---|---|
| Description | Comparison of dose exposures (Tmax) during once weekly administration of various doses of PB1046 |
| Time Frame | Pre-dose, Day 1 post-dose (1, 3, 24, 48, 72, 120 hours post-dose 1), Day 7, 14, 21 (1, 3, 24, 48, 72, 120 hours post-dose 4), Day 22, 23, 24, 26, 28, 29, 30, and 31. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety/Intent-to-Treat/Per Protocol Population. Only subjects with sufficient data analyzed. |
| Arm/Group Title | PB1046 Injection, 0.2 mg/kg | PB1046 Injection, 0.4 mg/kg | PB1046 Injection, 0.6 mg/kg | PB1046 Injection, 1.2 mg/kg |
|---|---|---|---|---|
| Arm/Group Description | Four weekly doses of PB1046 Injection, 0.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.4 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.6 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 1.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. |
| Measure Participants | 3 | 6 | 6 | 4 |
| Week 1 |
39.533
(14.1)
|
57.594
(54.0)
|
27.645
(15.7)
|
55.578
(35.8)
|
| Week 4 |
32.028
(13.7)
|
32.042
(12.2)
|
36.153
(13.6)
|
35.804
(13.9)
|
| Title | Pharmacokinetic Profile - Elimination Rate Constant (Lambda z) |
|---|---|
| Description | Comparison of dose exposures (lambda z) during once weekly administration of various doses of PB1046 |
| Time Frame | Pre-dose, Day 1 post-dose (1, 3, 24, 48, 72, 120 hours post-dose 1), Day 7, 14, 21 (1, 3, 24, 48, 72, 120 hours post-dose 4), Day 22, 23, 24, 26, 28, 29, 30, and 31. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety/Intent-to-Treat/Per Protocol Population. Only subjects with sufficient data analyzed. |
| Arm/Group Title | PB1046 Injection, 0.2 mg/kg | PB1046 Injection, 0.4 mg/kg | PB1046 Injection, 0.6 mg/kg | PB1046 Injection, 1.2 mg/kg |
|---|---|---|---|---|
| Arm/Group Description | Four weekly doses of PB1046 Injection, 0.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.4 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.6 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 1.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. |
| Measure Participants | 2 | 6 | 6 | 4 |
| Week 1 |
0.015
(0.0)
|
0.018
(0.0)
|
0.017
(0.0)
|
0.010
(0.0)
|
| Week 4 |
0.015
(0.0)
|
0.026
(0.0)
|
0.021
(0.0)
|
0.019
(0.0)
|
| Title | Pharmacokinetic Profile - Elimination Half-life (t½) |
|---|---|
| Description | Comparison of dose exposures (t½) during once weekly administration of various doses of PB1046 |
| Time Frame | Pre-dose, Day 1 post-dose (1, 3, 24, 48, 72, 120 hours post-dose 1), Day 7, 14, 21 (1, 3, 24, 48, 72, 120 hours post-dose 4), Day 22, 23, 24, 26, 28, 29, 30, and 31. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety/Intent-to-Treat/Per Protocol Population. Only subjects with sufficient data analyzed. |
| Arm/Group Title | PB1046 Injection, 0.2 mg/kg | PB1046 Injection, 0.4 mg/kg | PB1046 Injection, 0.6 mg/kg | PB1046 Injection, 1.2 mg/kg |
|---|---|---|---|---|
| Arm/Group Description | Four weekly doses of PB1046 Injection, 0.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.4 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.6 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 1.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. |
| Measure Participants | 2 | 6 | 6 | 4 |
| Week 1 |
45.787
(4.7)
|
40.806
(7.8)
|
54.735
(35.8)
|
103.951
(94.6)
|
| Week 4 |
78.382
(69.3)
|
28.333
(6.5)
|
34.602
(8.5)
|
44.902
(28.5)
|
| Title | Pharmacokinetic Profile - Clearance (CL/F), Uncorrected for Bioavailability |
|---|---|
| Description | Comparison of dose exposures (CL/F) during once weekly administration of various doses of PB1046 |
| Time Frame | Pre-dose, Day 1 post-dose (1, 3, 24, 48, 72, 120 hours post-dose 1), Day 7, 14, 21 (1, 3, 24, 48, 72, 120 hours post-dose 4), Day 22, 23, 24, 26, 28, 29, 30, and 31. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety/Intent-to-Treat/Per Protocol Population. Only subjects with sufficient data analyzed. |
| Arm/Group Title | PB1046 Injection, 0.2 mg/kg | PB1046 Injection, 0.4 mg/kg | PB1046 Injection, 0.6 mg/kg | PB1046 Injection, 1.2 mg/kg |
|---|---|---|---|---|
| Arm/Group Description | Four weekly doses of PB1046 Injection, 0.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.4 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.6 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 1.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. |
| Measure Participants | 2 | 6 | 6 | 4 |
| Week 1 |
31.992
(10.1)
|
33.145
(11.8)
|
37.376
(8.2)
|
36.067
(15.0)
|
| Week 4 |
26.981
(16.2)
|
28.443
(16.7)
|
39.940
(17.7)
|
49.220
(11.3)
|
| Title | Pharmacokinetic Profile - Volume of Distribution (Vz/F), Uncorrected for Bioavailability (F) |
|---|---|
| Description | Comparison of dose exposures (Vz/F) during once weekly administration of various doses of PB1046 |
| Time Frame | Pre-dose, Day 1 post-dose (1, 3, 24, 48, 72, 120 hours post-dose 1), Day 7, 14, 21 (1, 3, 24, 48, 72, 120 hours post-dose 4), Day 22, 23, 24, 26, 28, 29, 30, and 31. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety/Intent-to-Treat/Per Protocol Population. Only subjects with sufficient data analyzed. |
| Arm/Group Title | PB1046 Injection, 0.2 mg/kg | PB1046 Injection, 0.4 mg/kg | PB1046 Injection, 0.6 mg/kg | PB1046 Injection, 1.2 mg/kg |
|---|---|---|---|---|
| Arm/Group Description | Four weekly doses of PB1046 Injection, 0.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.4 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.6 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 1.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. |
| Measure Participants | 2 | 6 | 6 | 4 |
| Week 1 |
2079.049
(451.5)
|
1955.795
(826.8)
|
2983.922
(1951.6)
|
4774.976
(3297.6)
|
| Week 4 |
3860.362
(4528.5)
|
1246.900
(979.1)
|
2122.745
(1412.1)
|
3401.624
(2650.3)
|
| Title | Immunogenicity |
|---|---|
| Description | Number of participants reporting positive immunogenicity (four-fold increase of pre-dose titer) |
| Time Frame | Eleven weeks starting the first week of dosing. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety/Intent-to-Treat/Per Protocol Population |
| Arm/Group Title | PB1046 Injection, 0.2 mg/kg | PB1046 Injection, 0.4 mg/kg | PB1046 Injection, 0.6 mg/kg | PB1046 Injection, 1.2 mg/kg | Placebo Comparator |
|---|---|---|---|---|---|
| Arm/Group Description | Four weekly doses of PB1046 Injection, 0.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.4 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.6 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 1.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of Placebo (0.9% NaCl) Injection Placebo Injection: Four weekly subcutaneous injections of placebo. |
| Measure Participants | 3 | 6 | 7 | 6 | 7 |
| Number [subjects] |
2
|
2
|
3
|
6
|
0
|
Adverse Events
| Time Frame | 18 months | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||
| Arm/Group Title | PB1046 Injection, 0.2 mg/kg | PB1046 Injection, 0.4 mg/kg | PB1046 Injection, 0.6 mg/kg | PB1046 Injection, 1.2 mg/kg | Placebo Comparator | |||||
| Arm/Group Description | Four weekly doses of PB1046 Injection, 0.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.4 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 0.6 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of PB1046 Injection, 1.2 mg/kg PB1046 Injection: Four weekly subcutaneous injections of PB1046. | Four weekly doses of Placebo (0.9% NaCl) Injection Placebo Injection: Four weekly subcutaneous injections of placebo. | |||||
All Cause Mortality |
||||||||||
| PB1046 Injection, 0.2 mg/kg | PB1046 Injection, 0.4 mg/kg | PB1046 Injection, 0.6 mg/kg | PB1046 Injection, 1.2 mg/kg | Placebo Comparator | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/3 (0%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 0/7 (0%) | |||||
Serious Adverse Events |
||||||||||
| PB1046 Injection, 0.2 mg/kg | PB1046 Injection, 0.4 mg/kg | PB1046 Injection, 0.6 mg/kg | PB1046 Injection, 1.2 mg/kg | Placebo Comparator | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/3 (0%) | 1/6 (16.7%) | 0/7 (0%) | 0/6 (0%) | 0/7 (0%) | |||||
| Cardiac disorders | ||||||||||
| Atrial fibrillation | /3 (NaN) | 1/6 (16.7%) | 1/7 (14.3%) | 1/6 (16.7%) | 1/7 (14.3%) | |||||
| Blood creatinine increased | /3 (NaN) | 1/6 (16.7%) | 1/7 (14.3%) | 1/6 (16.7%) | 1/7 (14.3%) | |||||
| White blood cell count | /3 (NaN) | 1/6 (16.7%) | 1/7 (14.3%) | 1/6 (16.7%) | 1/7 (14.3%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| PB1046 Injection, 0.2 mg/kg | PB1046 Injection, 0.4 mg/kg | PB1046 Injection, 0.6 mg/kg | PB1046 Injection, 1.2 mg/kg | Placebo Comparator | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/3 (100%) | 6/6 (100%) | 7/7 (100%) | 6/6 (100%) | 0/7 (0%) | |||||
| Gastrointestinal disorders | ||||||||||
| Diarrhoea | 2/3 (66.7%) | 2 | 0/6 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 | 0/7 (0%) | 0 |
| General disorders | ||||||||||
| Injection site erythema | 3/3 (100%) | 20 | 6/6 (100%) | 40 | 7/7 (100%) | 34 | 6/6 (100%) | 28 | 0/7 (0%) | 0 |
| Injection site induration | 0/3 (0%) | 0 | 2/6 (33.3%) | 3 | 2/7 (28.6%) | 3 | 0/6 (0%) | 0 | 0/7 (0%) | 0 |
| Injection site pain | 2/3 (66.7%) | 9 | 2/6 (33.3%) | 5 | 2/7 (28.6%) | 10 | 6/6 (100%) | 14 | 0/7 (0%) | 0 |
| Injection site pruritus | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 1/7 (14.3%) | 1 | 2/6 (33.3%) | 4 | 0/7 (0%) | 0 |
| Injection site swelling | 1/3 (33.3%) | 4 | 2/6 (33.3%) | 4 | 4/7 (57.1%) | 5 | 2/6 (33.3%) | 3 | 0/7 (0%) | 0 |
| Injection site warmth | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/7 (14.3%) | 1 | 1/6 (16.7%) | 1 | 0/7 (0%) | 0 |
| Malaise | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/7 (0%) | 0 | 1/6 (16.7%) | 2 | 0/7 (0%) | 0 |
| Immune system disorders | ||||||||||
| Hypersensitivity | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/7 (0%) | 0 | 1/6 (16.7%) | 1 | 0/7 (0%) | 0 |
| Nervous system disorders | ||||||||||
| Burning sensation | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/7 (0%) | 0 | 1/6 (16.7%) | 1 | 0/7 (0%) | 0 |
| Dizziness | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/7 (14.3%) | 3 | 0/6 (0%) | 0 | 0/7 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||||
| Erythema | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 | 0/7 (0%) | 0 |
| Vascular disorders | ||||||||||
| Dizziness | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/7 (0%) | 0 | 1/6 (16.7%) | 1 | 0/7 (0%) | 0 |
| Flushing | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/7 (0%) | 0 | 1/6 (16.7%) | 2 | 0/7 (0%) | 0 |
| Orthostatic hypotension | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 2/7 (28.6%) | 2 | 1/6 (16.7%) | 1 | 0/7 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
PIs are not permitted to publish or discuss trial results until 5 years after study completion.
Results Point of Contact
| Name/Title | Dr. John Lee, Chief Medical Officer |
|---|---|
| Organization | PhaseBio |
| Phone | 6109816500 |
| john.lee@PhaseBio.com |
Responsible Party:
PhaseBio Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT02808585
Other Study ID Numbers:
- PB1046-PT-CL-0003-P1
First Posted:
Jun 22, 2016
Last Update Posted:
Jul 14, 2022
Last Verified:
Jun 1, 2022