Trial Outcomes & Findings for Study of CD388 Subcutaneous Administration in Healthy Japanese Subjects (NCT NCT05619536)
NCT ID: NCT05619536
Last Updated: 2024-10-01
Results Overview
Number of TEAEs reported, including but not limited to adverse events (AEs) and serious adverse events (SAEs) (including systemic reactogenicity/injection site reactions and hypersensitivity reactions), and AEs leading to study drug discontinuation and/or study withdrawal, based on vital signs, electrocardiogram (ECG), and clinical laboratory test (including hematology, coagulation, serum chemistry, and urinalysis) abnormalities following a single dose of CD388.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
28 participants
Primary outcome timeframe
From Day 1 through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others)
Results posted on
2024-10-01
Participant Flow
The planned total enrollment was 27 participants. One participant in the 150 milligram (mg) CD388 arm withdrew consent shortly after dosing and was replaced, resulting in an overall enrollment of 28 participants.
Participant milestones
| Measure |
50 mg CD388
7 participants randomized to receive a single dose of 50 mg CD388 via subcutaneous (SQ) injection
CD388 Injection: CD388 liquid for injection
|
150 mg CD388
8 participants randomized to receive a single dose of 150 mg CD388 via SQ injection
CD388 Injection: CD388 liquid for injection
|
450 mg CD388
7 participants randomized to receive a single dose of 450 mg CD388 via SQ injection
CD388 Injection: CD388 liquid for injection
|
Pooled Placebo
6 participants randomized to receive a single dose of saline placebo via SQ injection
Saline placebo: Sterile normal saline for injection
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
7
|
6
|
|
Overall Study
COMPLETED
|
7
|
6
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
1
|
1
|
Reasons for withdrawal
| Measure |
50 mg CD388
7 participants randomized to receive a single dose of 50 mg CD388 via subcutaneous (SQ) injection
CD388 Injection: CD388 liquid for injection
|
150 mg CD388
8 participants randomized to receive a single dose of 150 mg CD388 via SQ injection
CD388 Injection: CD388 liquid for injection
|
450 mg CD388
7 participants randomized to receive a single dose of 450 mg CD388 via SQ injection
CD388 Injection: CD388 liquid for injection
|
Pooled Placebo
6 participants randomized to receive a single dose of saline placebo via SQ injection
Saline placebo: Sterile normal saline for injection
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
0
|
Baseline Characteristics
Study of CD388 Subcutaneous Administration in Healthy Japanese Subjects
Baseline characteristics by cohort
| Measure |
50 mg CD388
n=7 Participants
7 participants randomized to receive a single dose of 50 mg CD388 via SQ injection
CD388 Injection: CD388 liquid for injection
|
150 mg CD388
n=8 Participants
8 participants randomized to receive a single dose of 150 mg CD388 via SQ injection
CD388 Injection: CD388 liquid for injection
|
450 mg CD388
n=7 Participants
7 participants randomized to receive a single dose of 450 mg CD388 via SQ injection
CD388 Injection: CD388 liquid for injection
|
Pooled Placebo
n=6 Participants
6 participants randomized to receive a single dose of saline placebo via SQ injection
Saline placebo: Sterile normal saline for injection
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
54.0 years
n=5 Participants
|
55.0 years
n=7 Participants
|
47.0 years
n=5 Participants
|
54.5 years
n=4 Participants
|
54.0 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
7 participants
n=5 Participants
|
6 participants
n=4 Participants
|
28 participants
n=21 Participants
|
|
Weight
|
61.50 kg
n=5 Participants
|
74.10 kg
n=7 Participants
|
77.10 kg
n=5 Participants
|
66.10 kg
n=4 Participants
|
67.15 kg
n=21 Participants
|
|
Height
|
161.20 cm
n=5 Participants
|
166.70 cm
n=7 Participants
|
173.30 cm
n=5 Participants
|
173.25 cm
n=4 Participants
|
169.20 cm
n=21 Participants
|
|
Body Mass Index (BMI)
|
22.70 kg/m^2
n=5 Participants
|
25.50 kg/m^2
n=7 Participants
|
24.80 kg/m^2
n=5 Participants
|
23.90 kg/m^2
n=4 Participants
|
24.25 kg/m^2
n=21 Participants
|
PRIMARY outcome
Timeframe: From Day 1 through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others)Population: The Safety Population included all participants who received any amount of study drug.
Number of TEAEs reported, including but not limited to adverse events (AEs) and serious adverse events (SAEs) (including systemic reactogenicity/injection site reactions and hypersensitivity reactions), and AEs leading to study drug discontinuation and/or study withdrawal, based on vital signs, electrocardiogram (ECG), and clinical laboratory test (including hematology, coagulation, serum chemistry, and urinalysis) abnormalities following a single dose of CD388.
Outcome measures
| Measure |
50 mg CD388
n=7 Participants
7 participants randomized to receive a single dose of 50 mg CD388 via subcutaneous (SQ) injection
CD388 Injection: CD388 liquid for injection
|
150 mg CD388
n=8 Participants
8 participants randomized to receive a single dose of 150 mg CD388 via SQ injection
CD388 Injection: CD388 liquid for injection
|
450 mg CD388
n=7 Participants
7 participants randomized to receive a single dose of 450 mg CD388 via SQ injection
CD388 Injection: CD388 liquid for injection
|
Pooled Placebo
n=6 Participants
6 participants randomized to receive a single dose of saline placebo via SQ injection
Saline placebo: Sterile normal saline for injection
|
|---|---|---|---|---|
|
Number of Treatment-Emergent Adverse Events (TEAEs) After a Single Dose of CD388
|
7 events
|
3 events
|
6 events
|
2 events
|
PRIMARY outcome
Timeframe: From Day 1 through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others)Population: The Safety Population included all participants who received any amount of study drug.
Severity of TEAEs reported, including but not limited to adverse events (AEs) and serious adverse events (SAEs) (including systemic reactogenicity/injection site reactions and hypersensitivity reactions), and AEs leading to study drug discontinuation and/or study withdrawal, based on vital signs, electrocardiogram (ECG), and clinical laboratory test (including hematology, coagulation, serum chemistry, and urinalysis) abnormalities following a single dose of CD388.
Outcome measures
| Measure |
50 mg CD388
n=7 Participants
7 participants randomized to receive a single dose of 50 mg CD388 via subcutaneous (SQ) injection
CD388 Injection: CD388 liquid for injection
|
150 mg CD388
n=8 Participants
8 participants randomized to receive a single dose of 150 mg CD388 via SQ injection
CD388 Injection: CD388 liquid for injection
|
450 mg CD388
n=7 Participants
7 participants randomized to receive a single dose of 450 mg CD388 via SQ injection
CD388 Injection: CD388 liquid for injection
|
Pooled Placebo
n=6 Participants
6 participants randomized to receive a single dose of saline placebo via SQ injection
Saline placebo: Sterile normal saline for injection
|
|---|---|---|---|---|
|
Severity of Treatment-Emergent Adverse Events (TEAEs) After a Single Dose of CD388
Grade 1 (Mild)
|
7 events
|
3 events
|
6 events
|
2 events
|
|
Severity of Treatment-Emergent Adverse Events (TEAEs) After a Single Dose of CD388
Grade 2 (Moderate)
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Severity of Treatment-Emergent Adverse Events (TEAEs) After a Single Dose of CD388
Grade 3 (Severe)
|
0 events
|
0 events
|
0 events
|
0 events
|
SECONDARY outcome
Timeframe: At inpatient visits on Days 1, 2, 3, 4, 5, 6, 7, 9, 11, and 14; and at outpatient visits on Day 30 (±3 days), Day 45 (±3 days), Day 60 (±5 days), Day 90 (±7 days), and either Day 120 (±14 days) (Cohort 1 only) or Day 165 (±14 days) (Cohorts 2 and 3 only)Population: The Pharmacokinetic (PK) Analysis Population included all participants who received a CD388 injection with at least one post-dose time point sampling. Participants who did not complete the sampling schedule may be included in the PK analysis for only the PK parameters that were judged not to be affected by the missing sample(s).
Evaluation of the maximum plasma concentration (Cmax) following subcutaneous administration of a single dose of CD388.
Outcome measures
| Measure |
50 mg CD388
n=7 Participants
7 participants randomized to receive a single dose of 50 mg CD388 via subcutaneous (SQ) injection
CD388 Injection: CD388 liquid for injection
|
150 mg CD388
n=7 Participants
8 participants randomized to receive a single dose of 150 mg CD388 via SQ injection
CD388 Injection: CD388 liquid for injection
|
450 mg CD388
n=7 Participants
7 participants randomized to receive a single dose of 450 mg CD388 via SQ injection
CD388 Injection: CD388 liquid for injection
|
Pooled Placebo
6 participants randomized to receive a single dose of saline placebo via SQ injection
Saline placebo: Sterile normal saline for injection
|
|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) Following CD388 Injection Administration
|
3.87 micrograms/milliliter (ug/mL)
Standard Deviation 0.776
|
13.5 micrograms/milliliter (ug/mL)
Standard Deviation 4.10
|
41.7 micrograms/milliliter (ug/mL)
Standard Deviation 9.27
|
—
|
SECONDARY outcome
Timeframe: At inpatient visits on Days 1, 2, 3, 4, 5, 6, 7, 9, 11, and 14; and at outpatient visits on Day 30 (±3 days), Day 45 (±3 days), Day 60 (±5 days), Day 90 (±7 days), and either Day 120 (±14 days) (Cohort 1 only) or Day 165 (±14 days) (Cohorts 2 and 3 only)Population: The PK Analysis Population included all participants who received a CD388 injection with at least one post-dose time point sampling. Participants who did not complete the sampling schedule may be included in the PK analysis for only the PK parameters that were judged not to be affected by the missing sample(s).
Evaluation of the time to maximum plasma concentration (Tmax) following subcutaneous administration of a single dose of CD388.
Outcome measures
| Measure |
50 mg CD388
n=7 Participants
7 participants randomized to receive a single dose of 50 mg CD388 via subcutaneous (SQ) injection
CD388 Injection: CD388 liquid for injection
|
150 mg CD388
n=7 Participants
8 participants randomized to receive a single dose of 150 mg CD388 via SQ injection
CD388 Injection: CD388 liquid for injection
|
450 mg CD388
n=7 Participants
7 participants randomized to receive a single dose of 450 mg CD388 via SQ injection
CD388 Injection: CD388 liquid for injection
|
Pooled Placebo
6 participants randomized to receive a single dose of saline placebo via SQ injection
Saline placebo: Sterile normal saline for injection
|
|---|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) Following CD388 Injection Administration
|
312.00 hours (h)
Interval 192.0 to 313.03
|
97.00 hours (h)
Interval 48.0 to 313.0
|
144.00 hours (h)
Interval 72.0 to 312.02
|
—
|
SECONDARY outcome
Timeframe: At inpatient visits on Days 1, 2, 3, 4, 5, 6, 7, 9, 11, and 14; and at outpatient visits on Day 30 (±3 days), Day 45 (±3 days), Day 60 (±5 days), Day 90 (±7 days), and either Day 120 (±14 days) (Cohort 1 only) or Day 165 (±14 days) (Cohorts 2 and 3 only)Population: The PK Analysis Population included all participants who received a CD388 injection with at least one post-dose time point sampling. Participants who did not complete the sampling schedule may be included in the PK analysis for only the PK parameters that were judged not to be affected by the missing sample(s).
Evaluation of the terminal elimination half-life (t½) following subcutaneous administration of a single dose of CD388.
Outcome measures
| Measure |
50 mg CD388
n=7 Participants
7 participants randomized to receive a single dose of 50 mg CD388 via subcutaneous (SQ) injection
CD388 Injection: CD388 liquid for injection
|
150 mg CD388
n=7 Participants
8 participants randomized to receive a single dose of 150 mg CD388 via SQ injection
CD388 Injection: CD388 liquid for injection
|
450 mg CD388
n=7 Participants
7 participants randomized to receive a single dose of 450 mg CD388 via SQ injection
CD388 Injection: CD388 liquid for injection
|
Pooled Placebo
6 participants randomized to receive a single dose of saline placebo via SQ injection
Saline placebo: Sterile normal saline for injection
|
|---|---|---|---|---|
|
Terminal Elimination Half-life (t½) Following CD388 Injection Administration
|
1325.86 hours (h)
Standard Deviation 289.24
|
1284.26 hours (h)
Standard Deviation 389.61
|
1210.10 hours (h)
Standard Deviation 193.31
|
—
|
SECONDARY outcome
Timeframe: At inpatient visits on Days 1, 2, 3, 4, 5, 6, 7, 9, 11, and 14; and at outpatient visits on Day 30 (±3 days), Day 45 (±3 days), Day 60 (±5 days), Day 90 (±7 days), and either Day 120 (±14 days) (Cohort 1 only) or Day 165 (±14 days) (Cohorts 2 and 3 only)Population: The PK Analysis Population included all participants who received a CD388 injection with at least one post-dose time point sampling. Participants who did not complete the sampling schedule may be included in the PK analysis for only the PK parameters that were judged not to be affected by the missing sample(s).
Evaluation of the apparent clearance (CL/F) following subcutaneous administration of a single dose of CD388.
Outcome measures
| Measure |
50 mg CD388
n=7 Participants
7 participants randomized to receive a single dose of 50 mg CD388 via subcutaneous (SQ) injection
CD388 Injection: CD388 liquid for injection
|
150 mg CD388
n=7 Participants
8 participants randomized to receive a single dose of 150 mg CD388 via SQ injection
CD388 Injection: CD388 liquid for injection
|
450 mg CD388
n=7 Participants
7 participants randomized to receive a single dose of 450 mg CD388 via SQ injection
CD388 Injection: CD388 liquid for injection
|
Pooled Placebo
6 participants randomized to receive a single dose of saline placebo via SQ injection
Saline placebo: Sterile normal saline for injection
|
|---|---|---|---|---|
|
Apparent Clearance (CL/F) Following CD388 Injection Administration
|
0.00653 liters/hour (L/h)
Standard Deviation 0.000529
|
0.00723 liters/hour (L/h)
Standard Deviation 0.00200
|
0.00764 liters/hour (L/h)
Standard Deviation 0.00144
|
—
|
SECONDARY outcome
Timeframe: At inpatient visits on Days 1, 2, 3, 4, 5, 6, 7, 9, 11, and 14; and at outpatient visits on Day 30 (±3 days), Day 45 (±3 days), Day 60 (±5 days), Day 90 (±7 days), and either Day 120 (±14 days) (Cohort 1 only) or Day 165 (±14 days) (Cohorts 2 and 3 only)Population: The PK Analysis Population included all participants who received a CD388 injection with at least one post-dose time point sampling. Participants who did not complete the sampling schedule may be included in the PK analysis for only the PK parameters that were judged not to be affected by the missing sample(s).
Evaluation of the apparent volume of distribution (VZ/F) following subcutaneous administration of a single dose of CD388.
Outcome measures
| Measure |
50 mg CD388
n=7 Participants
7 participants randomized to receive a single dose of 50 mg CD388 via subcutaneous (SQ) injection
CD388 Injection: CD388 liquid for injection
|
150 mg CD388
n=7 Participants
8 participants randomized to receive a single dose of 150 mg CD388 via SQ injection
CD388 Injection: CD388 liquid for injection
|
450 mg CD388
n=7 Participants
7 participants randomized to receive a single dose of 450 mg CD388 via SQ injection
CD388 Injection: CD388 liquid for injection
|
Pooled Placebo
6 participants randomized to receive a single dose of saline placebo via SQ injection
Saline placebo: Sterile normal saline for injection
|
|---|---|---|---|---|
|
Apparent Volume of Distribution (VZ/F) Following CD388 Injection Administration
|
12.5 liters (L)
Standard Deviation 2.87
|
12.6 liters (L)
Standard Deviation 3.42
|
13.3 liters (L)
Standard Deviation 3.10
|
—
|
SECONDARY outcome
Timeframe: At inpatient visits on Days 1, 2, 3, 4, 5, 6, 7, 9, 11, and 14; and at outpatient visits on Day 30 (±3 days), Day 45 (±3 days), Day 60 (±5 days), Day 90 (±7 days), and either Day 120 (±14 days) (Cohort 1 only) or Day 165 (±14 days) (Cohorts 2 and 3 only)Population: The PK Analysis Population included all participants who received a CD388 injection with at least one post-dose time point sampling. Participants who did not complete the sampling schedule may be included in the PK analysis for only the PK parameters that were judged not to be affected by the missing sample(s).
Evaluation of the area under the plasma concentration-time curve from time 0 to time of last quantifiable sample (AUC\[0-last\]) following subcutaneous administration of a single dose of CD388.
Outcome measures
| Measure |
50 mg CD388
n=7 Participants
7 participants randomized to receive a single dose of 50 mg CD388 via subcutaneous (SQ) injection
CD388 Injection: CD388 liquid for injection
|
150 mg CD388
n=7 Participants
8 participants randomized to receive a single dose of 150 mg CD388 via SQ injection
CD388 Injection: CD388 liquid for injection
|
450 mg CD388
n=7 Participants
7 participants randomized to receive a single dose of 450 mg CD388 via SQ injection
CD388 Injection: CD388 liquid for injection
|
Pooled Placebo
6 participants randomized to receive a single dose of saline placebo via SQ injection
Saline placebo: Sterile normal saline for injection
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-last]) Following CD388 Injection Administration
|
5880 ug*h/mL
Standard Deviation 615
|
18900 ug*h/mL
Standard Deviation 5730
|
53300 ug*h/mL
Standard Deviation 8320
|
—
|
SECONDARY outcome
Timeframe: At inpatient visits on Days 1, 2, 3, 4, 5, 6, 7, 9, 11, and 14; and at outpatient visits on Day 30 (±3 days), Day 45 (±3 days), Day 60 (±5 days), Day 90 (±7 days), and either Day 120 (±14 days) (Cohort 1 only) or Day 165 (±14 days) (Cohorts 2 and 3 only)Population: The PK Analysis Population included all participants who received a CD388 injection with at least one post-dose time point sampling. Participants who did not complete the sampling schedule may be included in the PK analysis for only the PK parameters that were judged not to be affected by the missing sample(s).
Evaluation of the area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC\[0-∞\]) following subcutaneous administration of a single dose of CD388.
Outcome measures
| Measure |
50 mg CD388
n=7 Participants
7 participants randomized to receive a single dose of 50 mg CD388 via subcutaneous (SQ) injection
CD388 Injection: CD388 liquid for injection
|
150 mg CD388
n=7 Participants
8 participants randomized to receive a single dose of 150 mg CD388 via SQ injection
CD388 Injection: CD388 liquid for injection
|
450 mg CD388
n=7 Participants
7 participants randomized to receive a single dose of 450 mg CD388 via SQ injection
CD388 Injection: CD388 liquid for injection
|
Pooled Placebo
6 participants randomized to receive a single dose of saline placebo via SQ injection
Saline placebo: Sterile normal saline for injection
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following CD388 Injection Administration
|
7700 ug*h/mL
Standard Deviation 657
|
22200 ug*h/mL
Standard Deviation 6390
|
60600 ug*h/mL
Standard Deviation 10700
|
—
|
Adverse Events
50 mg CD388
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
150 mg CD388
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
450 mg CD388
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Pooled Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
50 mg CD388
n=7 participants at risk
7 participants randomized to receive a single dose of 50 mg CD388 via SQ injection
CD388 Injection: CD388 liquid for injection
|
150 mg CD388
n=8 participants at risk
8 participants randomized to receive a single dose of 150 mg CD388 via SQ injection
CD388 Injection: CD388 liquid for injection
|
450 mg CD388
n=7 participants at risk
7 participants randomized to receive a single dose of 450 mg CD388 via SQ injection
CD388 Injection: CD388 liquid for injection
|
Pooled Placebo
n=6 participants at risk
6 participants randomized to receive a single dose of saline placebo via SQ injection
Saline placebo: Sterile normal saline for injection
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7 • Adverse events were collected for all participants from the time of signing the informed consent form through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others).
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all participants who received any amount of the study drug.
|
12.5%
1/8 • Adverse events were collected for all participants from the time of signing the informed consent form through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others).
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all participants who received any amount of the study drug.
|
0.00%
0/7 • Adverse events were collected for all participants from the time of signing the informed consent form through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others).
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all participants who received any amount of the study drug.
|
16.7%
1/6 • Adverse events were collected for all participants from the time of signing the informed consent form through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others).
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all participants who received any amount of the study drug.
|
|
General disorders
Fatigue
|
28.6%
2/7 • Adverse events were collected for all participants from the time of signing the informed consent form through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others).
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all participants who received any amount of the study drug.
|
0.00%
0/8 • Adverse events were collected for all participants from the time of signing the informed consent form through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others).
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all participants who received any amount of the study drug.
|
0.00%
0/7 • Adverse events were collected for all participants from the time of signing the informed consent form through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others).
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all participants who received any amount of the study drug.
|
16.7%
1/6 • Adverse events were collected for all participants from the time of signing the informed consent form through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others).
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all participants who received any amount of the study drug.
|
|
General disorders
Influenza like illness
|
14.3%
1/7 • Adverse events were collected for all participants from the time of signing the informed consent form through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others).
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all participants who received any amount of the study drug.
|
0.00%
0/8 • Adverse events were collected for all participants from the time of signing the informed consent form through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others).
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all participants who received any amount of the study drug.
|
0.00%
0/7 • Adverse events were collected for all participants from the time of signing the informed consent form through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others).
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all participants who received any amount of the study drug.
|
0.00%
0/6 • Adverse events were collected for all participants from the time of signing the informed consent form through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others).
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all participants who received any amount of the study drug.
|
|
General disorders
Injection site erythema
|
0.00%
0/7 • Adverse events were collected for all participants from the time of signing the informed consent form through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others).
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all participants who received any amount of the study drug.
|
12.5%
1/8 • Adverse events were collected for all participants from the time of signing the informed consent form through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others).
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all participants who received any amount of the study drug.
|
0.00%
0/7 • Adverse events were collected for all participants from the time of signing the informed consent form through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others).
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all participants who received any amount of the study drug.
|
0.00%
0/6 • Adverse events were collected for all participants from the time of signing the informed consent form through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others).
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all participants who received any amount of the study drug.
|
|
General disorders
Injection site hemorrhage
|
0.00%
0/7 • Adverse events were collected for all participants from the time of signing the informed consent form through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others).
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all participants who received any amount of the study drug.
|
0.00%
0/8 • Adverse events were collected for all participants from the time of signing the informed consent form through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others).
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all participants who received any amount of the study drug.
|
28.6%
2/7 • Adverse events were collected for all participants from the time of signing the informed consent form through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others).
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all participants who received any amount of the study drug.
|
0.00%
0/6 • Adverse events were collected for all participants from the time of signing the informed consent form through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others).
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all participants who received any amount of the study drug.
|
|
Infections and infestations
Asymptomatic COVID-19
|
14.3%
1/7 • Adverse events were collected for all participants from the time of signing the informed consent form through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others).
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all participants who received any amount of the study drug.
|
0.00%
0/8 • Adverse events were collected for all participants from the time of signing the informed consent form through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others).
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all participants who received any amount of the study drug.
|
14.3%
1/7 • Adverse events were collected for all participants from the time of signing the informed consent form through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others).
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all participants who received any amount of the study drug.
|
0.00%
0/6 • Adverse events were collected for all participants from the time of signing the informed consent form through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others).
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all participants who received any amount of the study drug.
|
|
Infections and infestations
COVID-19
|
14.3%
1/7 • Adverse events were collected for all participants from the time of signing the informed consent form through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others).
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all participants who received any amount of the study drug.
|
12.5%
1/8 • Adverse events were collected for all participants from the time of signing the informed consent form through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others).
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all participants who received any amount of the study drug.
|
0.00%
0/7 • Adverse events were collected for all participants from the time of signing the informed consent form through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others).
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all participants who received any amount of the study drug.
|
0.00%
0/6 • Adverse events were collected for all participants from the time of signing the informed consent form through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others).
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all participants who received any amount of the study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/7 • Adverse events were collected for all participants from the time of signing the informed consent form through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others).
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all participants who received any amount of the study drug.
|
0.00%
0/8 • Adverse events were collected for all participants from the time of signing the informed consent form through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others).
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all participants who received any amount of the study drug.
|
28.6%
2/7 • Adverse events were collected for all participants from the time of signing the informed consent form through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others).
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all participants who received any amount of the study drug.
|
0.00%
0/6 • Adverse events were collected for all participants from the time of signing the informed consent form through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others).
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all participants who received any amount of the study drug.
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • Adverse events were collected for all participants from the time of signing the informed consent form through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others).
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all participants who received any amount of the study drug.
|
0.00%
0/8 • Adverse events were collected for all participants from the time of signing the informed consent form through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others).
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all participants who received any amount of the study drug.
|
14.3%
1/7 • Adverse events were collected for all participants from the time of signing the informed consent form through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others).
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all participants who received any amount of the study drug.
|
0.00%
0/6 • Adverse events were collected for all participants from the time of signing the informed consent form through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others).
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all participants who received any amount of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/7 • Adverse events were collected for all participants from the time of signing the informed consent form through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others).
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all participants who received any amount of the study drug.
|
0.00%
0/8 • Adverse events were collected for all participants from the time of signing the informed consent form through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others).
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all participants who received any amount of the study drug.
|
14.3%
1/7 • Adverse events were collected for all participants from the time of signing the informed consent form through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others).
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all participants who received any amount of the study drug.
|
0.00%
0/6 • Adverse events were collected for all participants from the time of signing the informed consent form through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others).
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all participants who received any amount of the study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER