Trial Outcomes & Findings for A Clinical Study of the HIV Drug CPT31 in Healthy Volunteers (NCT NCT04672083)
NCT ID: NCT04672083
Last Updated: 2023-02-21
Results Overview
Number of subjects experiencing serious adverse events (SAEs)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Check-in (Day -1) through Follow-up (Day 28-30)
Results posted on
2023-02-21
Participant Flow
Participants were recruited at a single site in the United States between 16 November 2020 (date of first informed consent) and 29 April 2021 (date of last subject's last assessment).
32 subjects met inclusion criteria and were randomized to treatment.
Participant milestones
| Measure |
Cohort 1 0.01 mg/kg CPT31
6 subjects receiving a single subcutaneous injection of CPT31 (0.01 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 2 0.04 mg/kg CPT31
6 subjects receiving a single subcutaneous injection of CPT31 (0.04 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 3 0.12 mg/kg CPT31
6 subjects receiving a single subcutaneous injection of CPT31 (0.12 mg/kg) CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 4 0.24 mg/kg CPT31
6 subjects receiving a single subcutaneous injection of CPT31 (0.24 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Placebo
8 subjects receiving a single subcutaneous placebo injection
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
8
|
|
Overall Study
COMPLETED
|
5
|
6
|
6
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1 0.01 mg/kg CPT31
6 subjects receiving a single subcutaneous injection of CPT31 (0.01 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 2 0.04 mg/kg CPT31
6 subjects receiving a single subcutaneous injection of CPT31 (0.04 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 3 0.12 mg/kg CPT31
6 subjects receiving a single subcutaneous injection of CPT31 (0.12 mg/kg) CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 4 0.24 mg/kg CPT31
6 subjects receiving a single subcutaneous injection of CPT31 (0.24 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Placebo
8 subjects receiving a single subcutaneous placebo injection
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Clinical Study of the HIV Drug CPT31 in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Cohort 1 0.10 mg/kg CPT31
n=6 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.01 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 2 0.04 mg/kg CPT31
n=6 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.04 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 3 0.12 mg/kg CPT31
n=6 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.12 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 4 0.24 mg/kg CPT31
n=6 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.24 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Placebo
n=8 Participants
8 subjects receiving a single subcutaneous placebo injection
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
32 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Age, Continuous
|
41.0 years
STANDARD_DEVIATION 11.26 • n=93 Participants
|
41.8 years
STANDARD_DEVIATION 9.28 • n=4 Participants
|
25.2 years
STANDARD_DEVIATION 10.25 • n=27 Participants
|
38.7 years
STANDARD_DEVIATION 11.08 • n=483 Participants
|
38.5 years
STANDARD_DEVIATION 10.77 • n=36 Participants
|
37.1 years
STANDARD_DEVIATION 11.54 • n=10 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
11 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
21 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
16 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
16 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
12 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
19 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=93 Participants
|
6 participants
n=4 Participants
|
6 participants
n=27 Participants
|
6 participants
n=483 Participants
|
8 participants
n=36 Participants
|
32 participants
n=10 Participants
|
|
Body Mass Index (BMI)
|
24.32 kg/m^2
STANDARD_DEVIATION 5.426 • n=93 Participants
|
27.08 kg/m^2
STANDARD_DEVIATION 2.567 • n=4 Participants
|
23.45 kg/m^2
STANDARD_DEVIATION 3.026 • n=27 Participants
|
25.47 kg/m^2
STANDARD_DEVIATION 2.233 • n=483 Participants
|
25.00 kg/m^2
STANDARD_DEVIATION 2.898 • n=36 Participants
|
25.06 kg/m^2
STANDARD_DEVIATION 3.380 • n=10 Participants
|
PRIMARY outcome
Timeframe: Check-in (Day -1) through Follow-up (Day 28-30)Population: The safety population included all subjects who received at least 1 dose of study treatment (CPT31 or placebo).
Number of subjects experiencing serious adverse events (SAEs)
Outcome measures
| Measure |
Cohort 1 0.01 mg/kg CPT31
n=6 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.01 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 2 0.04 mg/kg CPT31
n=6 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.04 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 3 0.12 mg/kg CPT31
n=6 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.12 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 4 0.24 mg/kg CPT31
n=6 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.24 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Placebo
n=8 Participants
8 subjects receiving a single subcutaneous placebo injection
|
|---|---|---|---|---|---|
|
Adverse Events
|
0 participants experiencing adverse events
|
0 participants experiencing adverse events
|
0 participants experiencing adverse events
|
0 participants experiencing adverse events
|
0 participants experiencing adverse events
|
SECONDARY outcome
Timeframe: Day 1 predose, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, Day 2 (24 h), Day 3 (48 h), Day 4 (72 h), Day 5 (96 h), and Day 6 (120 h)Population: The pharmacokinetic (PK) population included all subjects who received at least 1 dose of CPT31 and had evaluable PK data.
maximum observed plasma concentration (ng/mL)
Outcome measures
| Measure |
Cohort 1 0.01 mg/kg CPT31
n=5 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.01 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 2 0.04 mg/kg CPT31
n=6 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.04 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 3 0.12 mg/kg CPT31
n=6 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.12 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 4 0.24 mg/kg CPT31
n=6 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.24 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Placebo
8 subjects receiving a single subcutaneous placebo injection
|
|---|---|---|---|---|---|
|
Cmax
|
27.6 ng/mL
Interval 22.7 to 39.4
|
91.0 ng/mL
Interval 45.1 to 144.0
|
247 ng/mL
Interval 147.0 to 487.0
|
666 ng/mL
Interval 393.0 to 1930.0
|
—
|
SECONDARY outcome
Timeframe: Day 1 predose, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, Day 2 (24 h), Day 3 (48 h), Day 4 (72 h), Day 5 (96 h), and Day 6 (120 h)Population: The PK population included all subjects who received at least 1 dose of CPT31 and had evaluable PK data.
time of maximum observed plasma concentration (h)
Outcome measures
| Measure |
Cohort 1 0.01 mg/kg CPT31
n=5 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.01 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 2 0.04 mg/kg CPT31
n=6 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.04 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 3 0.12 mg/kg CPT31
n=6 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.12 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 4 0.24 mg/kg CPT31
n=6 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.24 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Placebo
8 subjects receiving a single subcutaneous placebo injection
|
|---|---|---|---|---|---|
|
Tmax
|
6.00 Hours post administration
Interval 4.0 to 12.0
|
7.00 Hours post administration
Interval 4.0 to 16.0
|
7.00 Hours post administration
Interval 4.0 to 10.0
|
4.00 Hours post administration
Interval 0.5 to 24.0
|
—
|
SECONDARY outcome
Timeframe: Day 1 predose, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, Day 2 (24 h), Day 3 (48 h), Day 4 (72 h), Day 5 (96 h), and Day 6 (120 h)Population: Insufficient data for Cohorts 1\&2. No t1/2 estimate possible for 3 subjects in Cohorts 1\&2, and 1 in Cohort 4 as a reliable regression could not be fitted to the data. Per SAP: terminal elimination rate constant (λz) will only be calculated when a reliable estimate is obtained using ≥3 data points, and adjusted coefficient for determination of exponential fit (R2-adj) of the regression line is ≥0.7. Parameters requiring λz will only be calculated if R2-adj value of the regression is ≥0.7.
apparent plasma terminal elimination half-life (h)
Outcome measures
| Measure |
Cohort 1 0.01 mg/kg CPT31
n=5 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.01 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 2 0.04 mg/kg CPT31
n=6 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.04 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 3 0.12 mg/kg CPT31
n=6 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.12 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 4 0.24 mg/kg CPT31
n=5 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.24 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Placebo
8 subjects receiving a single subcutaneous placebo injection
|
|---|---|---|---|---|---|
|
T1/2
|
NA Hours post administration
One subject in Cohort 1 displayed plasma concentrations below the limit of quantification at all timepoints.
No t1/2 estimate was possible for 3 subjects in Cohort 1, 3 subjects in Cohort 2, and 1 subject in cohort 4 because a reliable regression could not be fitted to the data.
|
NA Hours post administration
One subject in Cohort 1 displayed plasma concentrations below the limit of quantification at all timepoints.
No t1/2 estimate was possible for 3 subjects in Cohort 1, 3 subjects in Cohort 2, and 1 subject in cohort 4 because a reliable regression could not be fitted to the data.
|
17.2 Hours post administration
Interval 14.2 to 20.8
|
15.2 Hours post administration
Interval 12.7 to 19.2
|
—
|
SECONDARY outcome
Timeframe: Day 1 predose, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, Day 2 (24 h), Day 3 (48 h), Day 4 (72 h), Day 5 (96 h), and Day 6 (120 h)Population: Insufficient data for Cohorts 1\&2. No (AUC)0-∞ estimate possible for 3 subjects in Cohorts 1\&2, and 1 in Cohort 4 as a reliable regression could not be fitted to the data. Per SAP: terminal elimination rate constant (λz) will only be calculated when a reliable estimate is obtained using ≥3 data points, and adjusted coefficient for determination of exponential fit (R2-adj) of the regression line is ≥0.7. Parameters requiring λz will only be calculated if R2-adj value of the regression is ≥0.7.
area under the concentration versus time curve (AUC) from time zero to infinity (h\*ng/mL)
Outcome measures
| Measure |
Cohort 1 0.01 mg/kg CPT31
n=5 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.01 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 2 0.04 mg/kg CPT31
n=6 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.04 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 3 0.12 mg/kg CPT31
n=6 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.12 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 4 0.24 mg/kg CPT31
n=6 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.24 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Placebo
8 subjects receiving a single subcutaneous placebo injection
|
|---|---|---|---|---|---|
|
Area Under the Concentration Curve (AUC) 0-∞
|
NA h*ng/mL
One subject in Cohort 1 displayed plasma concentrations below the limit of quantification at all timepoints.
No t1/2 estimate was possible for 3 subjects in Cohort 1, 3 subjects in Cohort 2, and 1 subject in cohort 4 because a reliable regression could not be fitted to the data.
|
NA h*ng/mL
One subject in Cohort 1 displayed plasma concentrations below the limit of quantification at all timepoints.
No t1/2 estimate was possible for 3 subjects in Cohort 1, 3 subjects in Cohort 2, and 1 subject in cohort 4 because a reliable regression could not be fitted to the data.
|
8170 h*ng/mL
Interval 6300.0 to 10900.0
|
21200 h*ng/mL
Interval 15400.0 to 28100.0
|
—
|
SECONDARY outcome
Timeframe: Day 1 predose, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, Day 2 (24 h), Day 3 (48 h), Day 4 (72 h), Day 5 (96 h), and Day 6 (120 h)Population: The PK population included all subjects who received at least 1 dose of CPT31 and had evaluable PK data.
area under the concentration versus time curve (AUC) from time zero to time of the last quantifiable concentration (h\*ng/mL)
Outcome measures
| Measure |
Cohort 1 0.01 mg/kg CPT31
n=5 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.01 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 2 0.04 mg/kg CPT31
n=6 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.04 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 3 0.12 mg/kg CPT31
n=6 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.12 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 4 0.24 mg/kg CPT31
n=6 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.24 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Placebo
8 subjects receiving a single subcutaneous placebo injection
|
|---|---|---|---|---|---|
|
AUC0-tlast
|
253 h*ng/mL
Interval 156.0 to 453.0
|
1660 h*ng/mL
Interval 919.0 to 2420.0
|
7000 h*ng/mL
Interval 4870.0 to 10500.0
|
19500 h*ng/mL
Interval 14500.0 to 27200.0
|
—
|
SECONDARY outcome
Timeframe: Day 1 predose, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, Day 2 (24 h), Day 3 (48 h), Day 4 (72 h), Day 5 (96 h), and Day 6 (120 h)Population: Insufficient data for Cohorts 1\&2. No CL/F estimate possible for 3 subjects in Cohorts 1\&2, and 1 in Cohort 4 as a reliable regression could not be fitted to the data. Per SAP: terminal elimination rate constant (λz) will only be calculated when a reliable estimate is obtained using ≥3 data points, and adjusted coefficient for determination of exponential fit (R2-adj) of the regression line is ≥0.7. Parameters requiring λz will only be calculated if R2-adj value of the regression is ≥0.7
apparent total plasma clearance (L/h/kg)
Outcome measures
| Measure |
Cohort 1 0.01 mg/kg CPT31
n=5 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.01 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 2 0.04 mg/kg CPT31
n=6 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.04 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 3 0.12 mg/kg CPT31
n=6 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.12 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 4 0.24 mg/kg CPT31
n=6 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.24 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Placebo
8 subjects receiving a single subcutaneous placebo injection
|
|---|---|---|---|---|---|
|
Total Plasma Clearance (CL/F)
|
NA L/h/kg
One subject in Cohort 1 displayed plasma concentrations below the limit of quantification at all timepoints.
No t1/2 estimate was possible for 3 subjects in Cohort 1, 3 subjects in Cohort 2, and 1 subject in cohort 4 because a reliable regression could not be fitted to the data.
|
NA L/h/kg
One subject in Cohort 1 displayed plasma concentrations below the limit of quantification at all timepoints.
No t1/2 estimate was possible for 3 subjects in Cohort 1, 3 subjects in Cohort 2, and 1 subject in cohort 4 because a reliable regression could not be fitted to the data.
|
17.2 L/h/kg
Interval 14.2 to 20.8
|
15.2 L/h/kg
Interval 12.7 to 19.2
|
—
|
SECONDARY outcome
Timeframe: Day 1 predose, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, Day 2 (24 h), Day 3 (48 h), Day 4 (72 h), Day 5 (96 h), and Day 6 (120 h)Population: Insufficient data for Cohorts 1\&2. No Vz/F estimate possible for 3 subjects in Cohorts 1\&2, and 1 in Cohort 4 as a reliable regression could not be fitted to the data. Per SAP: terminal elimination rate constant (λz) will only be calculated when a reliable estimate is obtained using ≥3 data points, and adjusted coefficient for determination of exponential fit (R2-adj) of the regression line is ≥0.7. Parameters requiring λz will only be calculated if R2-adj value of the regression is ≥0.7
apparent volume of distribution (L/kg)
Outcome measures
| Measure |
Cohort 1 0.01 mg/kg CPT31
n=5 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.01 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 2 0.04 mg/kg CPT31
n=6 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.04 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 3 0.12 mg/kg CPT31
n=6 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.12 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 4 0.24 mg/kg CPT31
n=6 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.24 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Placebo
8 subjects receiving a single subcutaneous placebo injection
|
|---|---|---|---|---|---|
|
Vz/F
|
NA L/kg
Insufficient data for Cohorts 1 and 2
|
NA L/kg
Insufficient data for Cohorts 1 and 2
|
0.365 L/kg
Interval 0.24 to 0.571
|
0.248 L/kg
Interval 0.192 to 0.431
|
—
|
SECONDARY outcome
Timeframe: Day 1 predose, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, Day 2 (24 h), Day 3 (48 h), Day 4 (72 h), Day 5 (96 h), and Day 6 (120 h)Population: Concentrations for all subjects in Cohorts 1-3 were below the limit of quantitation. Urine was not collected for Cohort 4.
amount of drug excreted in the urine (ng/mL)
Outcome measures
| Measure |
Cohort 1 0.01 mg/kg CPT31
n=5 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.01 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 2 0.04 mg/kg CPT31
n=6 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.04 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 3 0.12 mg/kg CPT31
n=6 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.12 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 4 0.24 mg/kg CPT31
6 subjects receiving a single subcutaneous injection of CPT31 (0.24 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Placebo
8 subjects receiving a single subcutaneous placebo injection
|
|---|---|---|---|---|---|
|
Ae
|
NA ng/mL
Concentrations for all subjects in Cohorts 1-3 were below the limit of quantitation.
|
NA ng/mL
Concentrations for all subjects in Cohorts 1-3 were below the limit of quantitation.
|
NA ng/mL
Concentrations for all subjects in Cohorts 1-3 were below the limit of quantitation.
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 predose, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, Day 2 (24 h), Day 3 (48 h), Day 4 (72 h), Day 5 (96 h), and Day 6 (120 h)Population: Concentrations for all subjects in Cohorts 1-3 were below the limit of quantitation. Urine was not collected for Cohort 4.
percentage of dose excreted unchanged in the urine (%)
Outcome measures
| Measure |
Cohort 1 0.01 mg/kg CPT31
n=5 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.01 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 2 0.04 mg/kg CPT31
n=6 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.04 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 3 0.12 mg/kg CPT31
n=6 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.12 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 4 0.24 mg/kg CPT31
6 subjects receiving a single subcutaneous injection of CPT31 (0.24 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Placebo
8 subjects receiving a single subcutaneous placebo injection
|
|---|---|---|---|---|---|
|
Fe
|
NA percentage of drug excreted unchanged
Concentrations for all subjects in Cohorts 1-3 were below the limit of quantitation.
|
NA percentage of drug excreted unchanged
Concentrations for all subjects in Cohorts 1-3 were below the limit of quantitation.
|
NA percentage of drug excreted unchanged
Concentrations for all subjects in Cohorts 1-3 were below the limit of quantitation.
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 predose, 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, Day 2 (24 h), Day 3 (48 h), Day 4 (72 h), Day 5 (96 h), and Day 6 (120 h)Population: Concentrations for all subjects in Cohorts 1-3 were below the limit of quantitation. Urine was not collected for Cohort 4.
renal clearance (L/h/kg)
Outcome measures
| Measure |
Cohort 1 0.01 mg/kg CPT31
n=5 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.01 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 2 0.04 mg/kg CPT31
n=6 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.04 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 3 0.12 mg/kg CPT31
n=6 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.12 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 4 0.24 mg/kg CPT31
6 subjects receiving a single subcutaneous injection of CPT31 (0.24 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Placebo
8 subjects receiving a single subcutaneous placebo injection
|
|---|---|---|---|---|---|
|
Renal Clearance (CLR)
|
NA L/h/kg
Standard Deviation NA
Concentrations for all subjects in Cohorts 1-3 were below the limit of quantitation.
|
NA L/h/kg
Standard Deviation NA
Concentrations for all subjects in Cohorts 1-3 were below the limit of quantitation.
|
NA L/h/kg
Standard Deviation NA
Concentrations for all subjects in Cohorts 1-3 were below the limit of quantitation.
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 through Follow-up (Day 28-30)Number of subjects with measurable levels of anti-CPT31 antibodies in serum
Outcome measures
| Measure |
Cohort 1 0.01 mg/kg CPT31
n=6 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.01 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 2 0.04 mg/kg CPT31
n=6 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.04 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 3 0.12 mg/kg CPT31
n=6 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.12 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 4 0.24 mg/kg CPT31
n=6 Participants
6 subjects receiving a single subcutaneous injection of CPT31 (0.24 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Placebo
n=8 Participants
8 subjects receiving a single subcutaneous placebo injection
|
|---|---|---|---|---|---|
|
Immunogenicity
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Cohort 1 0.01 mg/kg CPT31
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2 0.04 mg/kg CPT31
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 3 0.12 mg/kg CPT31
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 4 0.24 mg/kg CPT31
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1 0.01 mg/kg CPT31
n=6 participants at risk
6 subjects receiving a single subcutaneous injection of CPT31 (0.01 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 2 0.04 mg/kg CPT31
n=6 participants at risk
6 subjects receiving a single subcutaneous injection of CPT31 (0.04 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 3 0.12 mg/kg CPT31
n=6 participants at risk
6 subjects receiving a single subcutaneous injection of CPT31 (0.12 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Cohort 4 0.24 mg/kg CPT31
n=6 participants at risk
6 subjects receiving a single subcutaneous injection of CPT31 (0.24 mg/kg)
CPT31: CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
|
Placebo
n=8 participants at risk
8 subjects receiving a single subcutaneous placebo injection
|
|---|---|---|---|---|---|
|
General disorders
Injection Site Erythema
|
0.00%
0/6 • 30 days
Subjects will be observed for any signs or symptoms and asked about their condition by open questioning. Subjects will also be encouraged to spontaneously report adverse events (AEs) occurring at any other time during the study. All nonserious AEs, whether reported by the subject voluntarily or upon questioning, or noted on physical examination, will be recorded from initiation of study drug until study end. Serious AEs will be recorded from signing the informed consent form until study end.
|
0.00%
0/6 • 30 days
Subjects will be observed for any signs or symptoms and asked about their condition by open questioning. Subjects will also be encouraged to spontaneously report adverse events (AEs) occurring at any other time during the study. All nonserious AEs, whether reported by the subject voluntarily or upon questioning, or noted on physical examination, will be recorded from initiation of study drug until study end. Serious AEs will be recorded from signing the informed consent form until study end.
|
16.7%
1/6 • Number of events 1 • 30 days
Subjects will be observed for any signs or symptoms and asked about their condition by open questioning. Subjects will also be encouraged to spontaneously report adverse events (AEs) occurring at any other time during the study. All nonserious AEs, whether reported by the subject voluntarily or upon questioning, or noted on physical examination, will be recorded from initiation of study drug until study end. Serious AEs will be recorded from signing the informed consent form until study end.
|
83.3%
5/6 • Number of events 5 • 30 days
Subjects will be observed for any signs or symptoms and asked about their condition by open questioning. Subjects will also be encouraged to spontaneously report adverse events (AEs) occurring at any other time during the study. All nonserious AEs, whether reported by the subject voluntarily or upon questioning, or noted on physical examination, will be recorded from initiation of study drug until study end. Serious AEs will be recorded from signing the informed consent form until study end.
|
0.00%
0/8 • 30 days
Subjects will be observed for any signs or symptoms and asked about their condition by open questioning. Subjects will also be encouraged to spontaneously report adverse events (AEs) occurring at any other time during the study. All nonserious AEs, whether reported by the subject voluntarily or upon questioning, or noted on physical examination, will be recorded from initiation of study drug until study end. Serious AEs will be recorded from signing the informed consent form until study end.
|
|
General disorders
Injection Site Pain
|
0.00%
0/6 • 30 days
Subjects will be observed for any signs or symptoms and asked about their condition by open questioning. Subjects will also be encouraged to spontaneously report adverse events (AEs) occurring at any other time during the study. All nonserious AEs, whether reported by the subject voluntarily or upon questioning, or noted on physical examination, will be recorded from initiation of study drug until study end. Serious AEs will be recorded from signing the informed consent form until study end.
|
0.00%
0/6 • 30 days
Subjects will be observed for any signs or symptoms and asked about their condition by open questioning. Subjects will also be encouraged to spontaneously report adverse events (AEs) occurring at any other time during the study. All nonserious AEs, whether reported by the subject voluntarily or upon questioning, or noted on physical examination, will be recorded from initiation of study drug until study end. Serious AEs will be recorded from signing the informed consent form until study end.
|
16.7%
1/6 • Number of events 1 • 30 days
Subjects will be observed for any signs or symptoms and asked about their condition by open questioning. Subjects will also be encouraged to spontaneously report adverse events (AEs) occurring at any other time during the study. All nonserious AEs, whether reported by the subject voluntarily or upon questioning, or noted on physical examination, will be recorded from initiation of study drug until study end. Serious AEs will be recorded from signing the informed consent form until study end.
|
50.0%
3/6 • Number of events 3 • 30 days
Subjects will be observed for any signs or symptoms and asked about their condition by open questioning. Subjects will also be encouraged to spontaneously report adverse events (AEs) occurring at any other time during the study. All nonserious AEs, whether reported by the subject voluntarily or upon questioning, or noted on physical examination, will be recorded from initiation of study drug until study end. Serious AEs will be recorded from signing the informed consent form until study end.
|
0.00%
0/8 • 30 days
Subjects will be observed for any signs or symptoms and asked about their condition by open questioning. Subjects will also be encouraged to spontaneously report adverse events (AEs) occurring at any other time during the study. All nonserious AEs, whether reported by the subject voluntarily or upon questioning, or noted on physical examination, will be recorded from initiation of study drug until study end. Serious AEs will be recorded from signing the informed consent form until study end.
|
|
General disorders
Injection Site Induration
|
0.00%
0/6 • 30 days
Subjects will be observed for any signs or symptoms and asked about their condition by open questioning. Subjects will also be encouraged to spontaneously report adverse events (AEs) occurring at any other time during the study. All nonserious AEs, whether reported by the subject voluntarily or upon questioning, or noted on physical examination, will be recorded from initiation of study drug until study end. Serious AEs will be recorded from signing the informed consent form until study end.
|
0.00%
0/6 • 30 days
Subjects will be observed for any signs or symptoms and asked about their condition by open questioning. Subjects will also be encouraged to spontaneously report adverse events (AEs) occurring at any other time during the study. All nonserious AEs, whether reported by the subject voluntarily or upon questioning, or noted on physical examination, will be recorded from initiation of study drug until study end. Serious AEs will be recorded from signing the informed consent form until study end.
|
0.00%
0/6 • 30 days
Subjects will be observed for any signs or symptoms and asked about their condition by open questioning. Subjects will also be encouraged to spontaneously report adverse events (AEs) occurring at any other time during the study. All nonserious AEs, whether reported by the subject voluntarily or upon questioning, or noted on physical examination, will be recorded from initiation of study drug until study end. Serious AEs will be recorded from signing the informed consent form until study end.
|
50.0%
3/6 • Number of events 3 • 30 days
Subjects will be observed for any signs or symptoms and asked about their condition by open questioning. Subjects will also be encouraged to spontaneously report adverse events (AEs) occurring at any other time during the study. All nonserious AEs, whether reported by the subject voluntarily or upon questioning, or noted on physical examination, will be recorded from initiation of study drug until study end. Serious AEs will be recorded from signing the informed consent form until study end.
|
0.00%
0/8 • 30 days
Subjects will be observed for any signs or symptoms and asked about their condition by open questioning. Subjects will also be encouraged to spontaneously report adverse events (AEs) occurring at any other time during the study. All nonserious AEs, whether reported by the subject voluntarily or upon questioning, or noted on physical examination, will be recorded from initiation of study drug until study end. Serious AEs will be recorded from signing the informed consent form until study end.
|
|
General disorders
Injection Site Pruritis
|
0.00%
0/6 • 30 days
Subjects will be observed for any signs or symptoms and asked about their condition by open questioning. Subjects will also be encouraged to spontaneously report adverse events (AEs) occurring at any other time during the study. All nonserious AEs, whether reported by the subject voluntarily or upon questioning, or noted on physical examination, will be recorded from initiation of study drug until study end. Serious AEs will be recorded from signing the informed consent form until study end.
|
0.00%
0/6 • 30 days
Subjects will be observed for any signs or symptoms and asked about their condition by open questioning. Subjects will also be encouraged to spontaneously report adverse events (AEs) occurring at any other time during the study. All nonserious AEs, whether reported by the subject voluntarily or upon questioning, or noted on physical examination, will be recorded from initiation of study drug until study end. Serious AEs will be recorded from signing the informed consent form until study end.
|
16.7%
1/6 • Number of events 1 • 30 days
Subjects will be observed for any signs or symptoms and asked about their condition by open questioning. Subjects will also be encouraged to spontaneously report adverse events (AEs) occurring at any other time during the study. All nonserious AEs, whether reported by the subject voluntarily or upon questioning, or noted on physical examination, will be recorded from initiation of study drug until study end. Serious AEs will be recorded from signing the informed consent form until study end.
|
33.3%
2/6 • Number of events 2 • 30 days
Subjects will be observed for any signs or symptoms and asked about their condition by open questioning. Subjects will also be encouraged to spontaneously report adverse events (AEs) occurring at any other time during the study. All nonserious AEs, whether reported by the subject voluntarily or upon questioning, or noted on physical examination, will be recorded from initiation of study drug until study end. Serious AEs will be recorded from signing the informed consent form until study end.
|
0.00%
0/8 • 30 days
Subjects will be observed for any signs or symptoms and asked about their condition by open questioning. Subjects will also be encouraged to spontaneously report adverse events (AEs) occurring at any other time during the study. All nonserious AEs, whether reported by the subject voluntarily or upon questioning, or noted on physical examination, will be recorded from initiation of study drug until study end. Serious AEs will be recorded from signing the informed consent form until study end.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/6 • 30 days
Subjects will be observed for any signs or symptoms and asked about their condition by open questioning. Subjects will also be encouraged to spontaneously report adverse events (AEs) occurring at any other time during the study. All nonserious AEs, whether reported by the subject voluntarily or upon questioning, or noted on physical examination, will be recorded from initiation of study drug until study end. Serious AEs will be recorded from signing the informed consent form until study end.
|
0.00%
0/6 • 30 days
Subjects will be observed for any signs or symptoms and asked about their condition by open questioning. Subjects will also be encouraged to spontaneously report adverse events (AEs) occurring at any other time during the study. All nonserious AEs, whether reported by the subject voluntarily or upon questioning, or noted on physical examination, will be recorded from initiation of study drug until study end. Serious AEs will be recorded from signing the informed consent form until study end.
|
0.00%
0/6 • 30 days
Subjects will be observed for any signs or symptoms and asked about their condition by open questioning. Subjects will also be encouraged to spontaneously report adverse events (AEs) occurring at any other time during the study. All nonserious AEs, whether reported by the subject voluntarily or upon questioning, or noted on physical examination, will be recorded from initiation of study drug until study end. Serious AEs will be recorded from signing the informed consent form until study end.
|
0.00%
0/6 • 30 days
Subjects will be observed for any signs or symptoms and asked about their condition by open questioning. Subjects will also be encouraged to spontaneously report adverse events (AEs) occurring at any other time during the study. All nonserious AEs, whether reported by the subject voluntarily or upon questioning, or noted on physical examination, will be recorded from initiation of study drug until study end. Serious AEs will be recorded from signing the informed consent form until study end.
|
12.5%
1/8 • Number of events 1 • 30 days
Subjects will be observed for any signs or symptoms and asked about their condition by open questioning. Subjects will also be encouraged to spontaneously report adverse events (AEs) occurring at any other time during the study. All nonserious AEs, whether reported by the subject voluntarily or upon questioning, or noted on physical examination, will be recorded from initiation of study drug until study end. Serious AEs will be recorded from signing the informed consent form until study end.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/6 • 30 days
Subjects will be observed for any signs or symptoms and asked about their condition by open questioning. Subjects will also be encouraged to spontaneously report adverse events (AEs) occurring at any other time during the study. All nonserious AEs, whether reported by the subject voluntarily or upon questioning, or noted on physical examination, will be recorded from initiation of study drug until study end. Serious AEs will be recorded from signing the informed consent form until study end.
|
0.00%
0/6 • 30 days
Subjects will be observed for any signs or symptoms and asked about their condition by open questioning. Subjects will also be encouraged to spontaneously report adverse events (AEs) occurring at any other time during the study. All nonserious AEs, whether reported by the subject voluntarily or upon questioning, or noted on physical examination, will be recorded from initiation of study drug until study end. Serious AEs will be recorded from signing the informed consent form until study end.
|
0.00%
0/6 • 30 days
Subjects will be observed for any signs or symptoms and asked about their condition by open questioning. Subjects will also be encouraged to spontaneously report adverse events (AEs) occurring at any other time during the study. All nonserious AEs, whether reported by the subject voluntarily or upon questioning, or noted on physical examination, will be recorded from initiation of study drug until study end. Serious AEs will be recorded from signing the informed consent form until study end.
|
0.00%
0/6 • 30 days
Subjects will be observed for any signs or symptoms and asked about their condition by open questioning. Subjects will also be encouraged to spontaneously report adverse events (AEs) occurring at any other time during the study. All nonserious AEs, whether reported by the subject voluntarily or upon questioning, or noted on physical examination, will be recorded from initiation of study drug until study end. Serious AEs will be recorded from signing the informed consent form until study end.
|
12.5%
1/8 • Number of events 1 • 30 days
Subjects will be observed for any signs or symptoms and asked about their condition by open questioning. Subjects will also be encouraged to spontaneously report adverse events (AEs) occurring at any other time during the study. All nonserious AEs, whether reported by the subject voluntarily or upon questioning, or noted on physical examination, will be recorded from initiation of study drug until study end. Serious AEs will be recorded from signing the informed consent form until study end.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/6 • 30 days
Subjects will be observed for any signs or symptoms and asked about their condition by open questioning. Subjects will also be encouraged to spontaneously report adverse events (AEs) occurring at any other time during the study. All nonserious AEs, whether reported by the subject voluntarily or upon questioning, or noted on physical examination, will be recorded from initiation of study drug until study end. Serious AEs will be recorded from signing the informed consent form until study end.
|
0.00%
0/6 • 30 days
Subjects will be observed for any signs or symptoms and asked about their condition by open questioning. Subjects will also be encouraged to spontaneously report adverse events (AEs) occurring at any other time during the study. All nonserious AEs, whether reported by the subject voluntarily or upon questioning, or noted on physical examination, will be recorded from initiation of study drug until study end. Serious AEs will be recorded from signing the informed consent form until study end.
|
0.00%
0/6 • 30 days
Subjects will be observed for any signs or symptoms and asked about their condition by open questioning. Subjects will also be encouraged to spontaneously report adverse events (AEs) occurring at any other time during the study. All nonserious AEs, whether reported by the subject voluntarily or upon questioning, or noted on physical examination, will be recorded from initiation of study drug until study end. Serious AEs will be recorded from signing the informed consent form until study end.
|
0.00%
0/6 • 30 days
Subjects will be observed for any signs or symptoms and asked about their condition by open questioning. Subjects will also be encouraged to spontaneously report adverse events (AEs) occurring at any other time during the study. All nonserious AEs, whether reported by the subject voluntarily or upon questioning, or noted on physical examination, will be recorded from initiation of study drug until study end. Serious AEs will be recorded from signing the informed consent form until study end.
|
12.5%
1/8 • Number of events 1 • 30 days
Subjects will be observed for any signs or symptoms and asked about their condition by open questioning. Subjects will also be encouraged to spontaneously report adverse events (AEs) occurring at any other time during the study. All nonserious AEs, whether reported by the subject voluntarily or upon questioning, or noted on physical examination, will be recorded from initiation of study drug until study end. Serious AEs will be recorded from signing the informed consent form until study end.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place