Trial Outcomes & Findings for First-in-human Study of Safety, Pharmacokinetics and Pharmacodynamics of Various Doses of BCD-089 in Healthy Subjects (NCT NCT03103438)
NCT ID: NCT03103438
Last Updated: 2021-02-26
Results Overview
Area Under the Plasma Concentration of BCD-089-time Curve From Zero (0) Hours to 1680 Hours After the Single Subcutaneous Injection of BCD-089.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
19 participants
Primary outcome timeframe
70 days
Results posted on
2021-02-26
Participant Flow
Participant milestones
| Measure |
Cohort 1
One subject received the maximum safe starting dose of BCD-089 (0.06 mg/kg) subcutaneously.
|
Cohort 2
Three subjects received the single subcutaneous injection of BCD-089 at a dose of 0.3 mg/kg.
|
Cohort 3
Three subjects received the single subcutaneous injection of BCD-089 at a dose of 0.625 mg/kg.
|
Cohort 4
Three subjects received the single subcutaneous injection of BCD-089 at a dose of 1.0 mg/kg.
|
Cohort 5
Three subjects received the single subcutaneous injection of BCD-089 at a dose of 1.6 mg/kg.
|
Cohort 6
Three subjects received the single subcutaneous injection of BCD-089 at a dose of 2.2 mg/kg.
|
Cohort 7
Three subjects received the single subcutaneous injection of BCD-089 at a dose of 2.9 mg/kg.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
1
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
First-in-human Study of Safety, Pharmacokinetics and Pharmacodynamics of Various Doses of BCD-089 in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Cohort 1
n=1 Participants
One subject received the maximum safe starting dose of BCD-089 (0.06 mg/kg) subcutaneously.
|
Cohort 2
n=3 Participants
Three subjects received the single subcutaneous injection of BCD-089 at a dose of 0.3 mg/kg.
|
Cohort 3
n=3 Participants
Three subjects received the single subcutaneous injection of BCD-089 at a dose of 0.625 mg/kg.
|
Cohort 4
n=3 Participants
Three subjects received the single subcutaneous injection of BCD-089 at a dose of 1.0 mg/kg.
|
Cohort 5
n=3 Participants
Three subjects received the single subcutaneous injection of BCD-089 at a dose of 1.6 mg/kg.
|
Cohort 6
n=3 Participants
Three subjects received the single subcutaneous injection of BCD-089 at a dose of 2.2 mg/kg.
|
Cohort 7
n=3 Participants
Three subjects received the single subcutaneous injection of BCD-089 at a dose of 2.9 mg/kg.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
25 years
n=5 Participants
|
28 years
n=7 Participants
|
22 years
n=5 Participants
|
23 years
n=4 Participants
|
27 years
n=21 Participants
|
22 years
n=10 Participants
|
26 years
n=115 Participants
|
25 years
n=24 Participants
|
|
Sex: Female, Male
Female
|
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
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
19 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
19 Participants
n=24 Participants
|
|
Region of Enrollment
Russia
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
3 participants
n=21 Participants
|
3 participants
n=10 Participants
|
3 participants
n=115 Participants
|
19 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 70 daysPopulation: The pharmacokinetic analysis population included the data from all volunteers included in the study (n = 19).
Area Under the Plasma Concentration of BCD-089-time Curve From Zero (0) Hours to 1680 Hours After the Single Subcutaneous Injection of BCD-089.
Outcome measures
| Measure |
Cohort 1
n=1 Participants
One subject received the maximum safe starting dose of BCD-089 (0.06 mg/kg) subcutaneously.
|
Cohort 2
n=3 Participants
Three subjects received the single subcutaneous injection of BCD-089 at a dose of 0.3 mg/kg.
|
Cohort 3
n=3 Participants
Three subjects received the single subcutaneous injection of BCD-089 at a dose of 0.625 mg/kg.
|
Cohort 4
n=3 Participants
Three subjects received the single subcutaneous injection of BCD-089 at a dose of 1.0 mg/kg.
|
Cohort 5
n=3 Participants
Three subjects received the single subcutaneous injection of BCD-089 at a dose of 1.6 mg/kg.
|
Cohort 6
n=3 Participants
Three subjects received the single subcutaneous injection of BCD-089 at a dose of 2.2 mg/kg.
|
Cohort 7
n=3 Participants
Three subjects received the single subcutaneous injection of BCD-089 at a dose of 2.9 mg/kg.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration of BCD-089-time Curve From Zero (0) Hours to 1680 Hours After the Single Subcutaneous Injection of BCD-089
|
0 ng/ml*h
Interval 0.0 to 0.0
|
15567.9 ng/ml*h
Interval 8364.0 to 18664.2
|
44568.6 ng/ml*h
Interval 14441.2 to 50635.4
|
588202.2 ng/ml*h
Interval 160711.0 to 1044464.2
|
1208489.2 ng/ml*h
Interval 777536.3 to 1352794.3
|
4190342.2 ng/ml*h
Interval 3891917.6 to 6676172.8
|
10512592.4 ng/ml*h
Interval 8628174.9 to 10759494.4
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 4
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 5
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 6
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 7
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
n=1 participants at risk
One subject received the maximum safe starting dose of BCD-089 (0.06 mg/kg) subcutaneously.
|
Cohort 2
n=3 participants at risk
Three subjects received the single subcutaneous injection of BCD-089 at a dose of 0.3 mg/kg.
|
Cohort 3
n=3 participants at risk
Three subjects received the single subcutaneous injection of BCD-089 at a dose of 0.625 mg/kg.
|
Cohort 4
n=3 participants at risk
Three subjects received the single subcutaneous injection of BCD-089 at a dose of 1.0 mg/kg.
|
Cohort 5
n=3 participants at risk
Three subjects received the single subcutaneous injection of BCD-089 at a dose of 1.6 mg/kg.
|
Cohort 6
n=3 participants at risk
Three subjects received the single subcutaneous injection of BCD-089 at a dose of 2.2 mg/kg.
|
Cohort 7
n=3 participants at risk
Three subjects received the single subcutaneous injection of BCD-089 at a dose of 2.9 mg/kg.
|
|---|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
AST decreased
|
0.00%
0/1 • 71 days from the moment of injection
|
33.3%
1/3 • Number of events 1 • 71 days from the moment of injection
|
0.00%
0/3 • 71 days from the moment of injection
|
0.00%
0/3 • 71 days from the moment of injection
|
0.00%
0/3 • 71 days from the moment of injection
|
0.00%
0/3 • 71 days from the moment of injection
|
0.00%
0/3 • 71 days from the moment of injection
|
|
Hepatobiliary disorders
total bilirubin increased
|
0.00%
0/1 • 71 days from the moment of injection
|
0.00%
0/3 • 71 days from the moment of injection
|
33.3%
1/3 • Number of events 1 • 71 days from the moment of injection
|
0.00%
0/3 • 71 days from the moment of injection
|
0.00%
0/3 • 71 days from the moment of injection
|
0.00%
0/3 • 71 days from the moment of injection
|
0.00%
0/3 • 71 days from the moment of injection
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/1 • 71 days from the moment of injection
|
0.00%
0/3 • 71 days from the moment of injection
|
0.00%
0/3 • 71 days from the moment of injection
|
33.3%
1/3 • Number of events 1 • 71 days from the moment of injection
|
0.00%
0/3 • 71 days from the moment of injection
|
66.7%
2/3 • Number of events 2 • 71 days from the moment of injection
|
33.3%
1/3 • Number of events 1 • 71 days from the moment of injection
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1 • 71 days from the moment of injection
|
0.00%
0/3 • 71 days from the moment of injection
|
0.00%
0/3 • 71 days from the moment of injection
|
33.3%
1/3 • Number of events 2 • 71 days from the moment of injection
|
0.00%
0/3 • 71 days from the moment of injection
|
66.7%
2/3 • Number of events 2 • 71 days from the moment of injection
|
33.3%
1/3 • Number of events 1 • 71 days from the moment of injection
|
|
Renal and urinary disorders
creatinine decreased
|
0.00%
0/1 • 71 days from the moment of injection
|
0.00%
0/3 • 71 days from the moment of injection
|
33.3%
1/3 • Number of events 1 • 71 days from the moment of injection
|
0.00%
0/3 • 71 days from the moment of injection
|
0.00%
0/3 • 71 days from the moment of injection
|
0.00%
0/3 • 71 days from the moment of injection
|
0.00%
0/3 • 71 days from the moment of injection
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place