Trial Outcomes & Findings for Comparative Clinical Study of Pharmacokinetics, Tolerance and Safety of BCD-057 and Humira in Healthy Volunteers (NCT NCT02395055)
NCT ID: NCT02395055
Last Updated: 2021-11-05
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
94 participants
Primary outcome timeframe
0, 6, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-dose
Results posted on
2021-11-05
Participant Flow
Participant milestones
| Measure |
BCD-057 Group
BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
|
Humira Group
Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
47
|
|
Overall Study
COMPLETED
|
40
|
44
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
Reasons for withdrawal
| Measure |
BCD-057 Group
BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
|
Humira Group
Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
3
|
Baseline Characteristics
Comparative Clinical Study of Pharmacokinetics, Tolerance and Safety of BCD-057 and Humira in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
BCD-057 Group
n=40 Participants
BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
|
Humira Group
n=44 Participants
Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
24.5 years
n=5 Participants
|
25.5 years
n=7 Participants
|
25 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0, 6, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-dosePopulation: All patients who received one injection of adalimumab.
Outcome measures
| Measure |
BCD-057 Group
n=40 Participants
BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
|
Humira Group
n=44 Participants
Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
|
|---|---|---|
|
Maximum Concentration of Adalimumab After Single SC Injection of BCD-057/Humira
|
4426 ng/ml
Interval 3524.0 to 5902.0
|
4522 ng/ml
Interval 3546.0 to 5104.0
|
PRIMARY outcome
Timeframe: 0, 6, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-dosePopulation: All patients who received adalimumab injection.
Outcome measures
| Measure |
BCD-057 Group
n=40 Participants
BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
|
Humira Group
n=44 Participants
Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
|
|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Zero (0) to Time Infinity
|
2488188 (ng/ml)*hour
Interval 1809194.0 to 2827564.0
|
2272029 (ng/ml)*hour
Interval 1815831.0 to 2904679.0
|
SECONDARY outcome
Timeframe: 0, 6, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-dosePopulation: All volunteers who received one adalimumab injection.
Outcome measures
| Measure |
BCD-057 Group
n=40 Participants
BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
|
Humira Group
n=44 Participants
Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
|
|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 1680 Hours of Adalimumab After Single SC Injection of BCD-057/Humira.
|
2488187 (ng/ml)*hour
Interval 1809193.0 to 2778993.0
|
2272029 (ng/ml)*hour
Interval 1815831.0 to 2858812.0
|
SECONDARY outcome
Timeframe: 0, 6, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-doseOutcome measures
| Measure |
BCD-057 Group
n=40 Participants
BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
|
Humira Group
n=44 Participants
Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
|
|---|---|---|
|
Time to Reach Maximum Concentration of Adalimumab After Single Subcutaneous Injection of BCD-057/Humira
|
120 hours
Interval 96.0 to 192.0
|
108 hours
Interval 90.0 to 150.0
|
SECONDARY outcome
Timeframe: 0, 6, 24, 48, 72, 96,120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-doseOutcome measures
| Measure |
BCD-057 Group
n=40 Participants
BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
|
Humira Group
n=44 Participants
Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
|
|---|---|---|
|
Half-life Period of Adalimumab After Single Subcutaneous Injection of BCD-057/Humira
|
263.35 hours
Interval 194.65 to 351.61
|
269.68 hours
Interval 196.29 to 317.01
|
SECONDARY outcome
Timeframe: 0, 6, 24, 48, 72, 96,120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-doseOutcome measures
| Measure |
BCD-057 Group
n=40 Participants
BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
|
Humira Group
n=44 Participants
Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
|
|---|---|---|
|
Volume of Distribution of Adalimumab After Single Administration of BCD-057/Humira
|
7165.85 ml/kg
Interval 5105.07 to 8482.38
|
6622.06 ml/kg
Interval 5637.07 to 7854.49
|
SECONDARY outcome
Timeframe: 0, 6, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-doseOutcome measures
| Measure |
BCD-057 Group
n=40 Participants
BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
|
Humira Group
n=44 Participants
Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
|
|---|---|---|
|
Clearance of Adalimumab After Single Subcutaneous Injection of BCD-057/ Humira
|
16.08 ml/(h*kg)
Interval 14.39 to 22.11
|
17.61 ml/(h*kg)
Interval 13.99 to 22.04
|
SECONDARY outcome
Timeframe: 0, 6, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-doseOutcome measures
| Measure |
BCD-057 Group
n=40 Participants
BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
|
Humira Group
n=44 Participants
Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
|
|---|---|---|
|
Elimination Rate Constant of Adalimumab After Single Subcutaneous Injection of BCD-057/Humira
|
0.003 fraction of drug eliminated per hour
Interval 0.002 to 0.004
|
0.003 fraction of drug eliminated per hour
Interval 0.002 to 0.004
|
Adverse Events
BCD-057 Group
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Humira Group
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BCD-057 Group
n=40 participants at risk
BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
|
Humira Group
n=44 participants at risk
Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
|
|---|---|---|
|
Blood and lymphatic system disorders
Leucopenia
|
2.5%
1/40 • 70 days
|
4.5%
2/44 • 70 days
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.0%
2/40 • 70 days
|
2.3%
1/44 • 70 days
|
|
Blood and lymphatic system disorders
Monocytosis
|
5.0%
2/40 • 70 days
|
0.00%
0/44 • 70 days
|
|
Blood and lymphatic system disorders
Monocytopenia
|
5.0%
2/40 • 70 days
|
2.3%
1/44 • 70 days
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
5.0%
2/40 • 70 days
|
4.5%
2/44 • 70 days
|
|
Hepatobiliary disorders
Elevated ALT
|
7.5%
3/40 • 70 days
|
25.0%
11/44 • 70 days
|
|
Hepatobiliary disorders
Elevated AST
|
7.5%
3/40 • 70 days
|
6.8%
3/44 • 70 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place