Trial Outcomes & Findings for First-in-human Study to Evaluate Safety, Tolerability and Pharmacokinetics of Various Doses of BCD-085 in Healthy Subjects (NCT NCT02380287)
NCT ID: NCT02380287
Last Updated: 2021-03-03
Results Overview
The blood sampling for the pharmacokinetic evaluations was performed at the following time points: 0 h (5 min before the injection) and at 0.5 hours, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours,168 hours, 336 hours, 504 hours, 672 hours, 840 hours, 1008 hours, 1176 hours, and 1344 hours following the drug administration.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
22 participants
Primary outcome timeframe
56 days
Results posted on
2021-03-03
Participant Flow
Participant milestones
| Measure |
Cohort no.1
This cohort includes just one subject who will receive the maximum safe starting dose of BCD-085 (0.05 mg/kg) subcutaneously. If the dose limitating toxicity occurs within the first seven days after injection the study will be stopped. If there is no DLT within mentioned above period then Cohort no.2 is included.
humanized monoclonal antibody against human IL-17
|
Cohort no.2
This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 0.05 mg/kg.
If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 3 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 3.
humanized monoclonal antibody against human IL-17
|
Cohort no.3
This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 0.25 mg/kg.
If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 4 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 4.
humanized monoclonal antibody against human IL-17
|
Cohort no.4
This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 0.825 mg/kg.
If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 5 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 5.
humanized monoclonal antibody against human IL-17
|
Cohort no.5
This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 1.25 mg/kg.
If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 6 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 6.
humanized monoclonal antibody against human IL-17
|
Cohort no.6
This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 1.75 mg/kg.
If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 7 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 7.
humanized monoclonal antibody against human IL-17
|
Cohort no.7
This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 2.25 mg/kg.
If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 8 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 8.
humanized monoclonal antibody against human IL-17
|
Cohort no.8
This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.
If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level.
humanized monoclonal antibody against human IL-17
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
1
|
3
|
2
|
3
|
3
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort no.1
This cohort includes just one subject who will receive the maximum safe starting dose of BCD-085 (0.05 mg/kg) subcutaneously. If the dose limitating toxicity occurs within the first seven days after injection the study will be stopped. If there is no DLT within mentioned above period then Cohort no.2 is included.
humanized monoclonal antibody against human IL-17
|
Cohort no.2
This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 0.05 mg/kg.
If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 3 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 3.
humanized monoclonal antibody against human IL-17
|
Cohort no.3
This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 0.25 mg/kg.
If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 4 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 4.
humanized monoclonal antibody against human IL-17
|
Cohort no.4
This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 0.825 mg/kg.
If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 5 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 5.
humanized monoclonal antibody against human IL-17
|
Cohort no.5
This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 1.25 mg/kg.
If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 6 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 6.
humanized monoclonal antibody against human IL-17
|
Cohort no.6
This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 1.75 mg/kg.
If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 7 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 7.
humanized monoclonal antibody against human IL-17
|
Cohort no.7
This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 2.25 mg/kg.
If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 8 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 8.
humanized monoclonal antibody against human IL-17
|
Cohort no.8
This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.
If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level.
humanized monoclonal antibody against human IL-17
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
First-in-human Study to Evaluate Safety, Tolerability and Pharmacokinetics of Various Doses of BCD-085 in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Cohort no.1
n=1 Participants
This cohort includes just one subject who received the maximum safe starting dose of BCD-085 (0.05 mg/kg) subcutaneously.
|
Cohort no.2
n=3 Participants
This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.05 mg/kg.
|
Cohort no.3
n=3 Participants
This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.25 mg/kg.
|
Cohort no.4
n=3 Participants
This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.825 mg/kg.
|
Cohort no.5
n=3 Participants
This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.25 mg/kg.
|
Cohort no.6
n=3 Participants
This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.75 mg/kg.
|
Cohort no.7
n=3 Participants
This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 2.25 mg/kg.
|
Cohort no.8
n=3 Participants
This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.
|
Total
n=22 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
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=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
22 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 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=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
22 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: 56 daysPopulation: The analysis population includes all subjects for whom not more than 2 blood samples for BCD-085 assay were missing or unevaluable, and for whom no violations of blood sampling schedule were reported. Results of PK parameters consider in Cohort 1 and 2 together since the same dose were injected.
The blood sampling for the pharmacokinetic evaluations was performed at the following time points: 0 h (5 min before the injection) and at 0.5 hours, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours,168 hours, 336 hours, 504 hours, 672 hours, 840 hours, 1008 hours, 1176 hours, and 1344 hours following the drug administration.
Outcome measures
| Measure |
Cohort 1 + Cohort 2
n=4 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.05 mg/kg.
|
Cohort 3
n=2 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.25 mg/kg.
|
Cohort 4
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.825 mg/kg.
|
Cohort 5
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.25 mg/kg.
|
Cohort 6
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.75 mg/kg.
|
Cohort 7
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 2.25 mg/kg.
|
Cohort 8
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.
|
Cohort 8
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration of BCD-085-time Curve From Zero (0) Hours to 1344 Hours After the Single Subcutaneous Injection of BCD-085
|
594222.00 (ng/ml)*hour
Interval 583105.25 to 597706.25
|
2262670.25 (ng/ml)*hour
Interval 1600708.75 to 2924631.75
|
5669903.75 (ng/ml)*hour
Interval 5566847.0 to 7958067.25
|
9939951.75 (ng/ml)*hour
Interval 8169096.25 to 10963413.25
|
9220825.00 (ng/ml)*hour
Interval 6191133.5 to 11536130.0
|
14915081.50 (ng/ml)*hour
Interval 13047990.5 to 14963820.5
|
10152522550.50 (ng/ml)*hour
Interval 9119054864.0 to 11931556230.0
|
—
|
SECONDARY outcome
Timeframe: 56 daysPopulation: The analysis population includes all subjects for whom not more than 2 blood samples for BCD-085 assay were missing or unevaluable, and for whom no violations of blood sampling schedule were reported. Results of PK parameters consider in Cohort 1 and 2 together since the same dose were injected.
To assess the maximum observed concentration (Cmax) following single SC administer regardless of the cohort
Outcome measures
| Measure |
Cohort 1 + Cohort 2
n=4 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.05 mg/kg.
|
Cohort 3
n=2 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.25 mg/kg.
|
Cohort 4
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.825 mg/kg.
|
Cohort 5
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.25 mg/kg.
|
Cohort 6
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.75 mg/kg.
|
Cohort 7
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 2.25 mg/kg.
|
Cohort 8
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.
|
Cohort 8
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Concentration of BCD-085 After Single Subcutaneous Injection
|
583.5 ng/mL
Standard Deviation 53.3
|
2566.00 ng/mL
Standard Deviation 504.87
|
8970.67 ng/mL
Standard Deviation 1831.26
|
12946.67 ng/mL
Standard Deviation 1744.52
|
12415.33 ng/mL
Standard Deviation 4280.65
|
20115.00 ng/mL
Standard Deviation 1413.55
|
28691.33 ng/mL
Standard Deviation 1478.00
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 56 daysPopulation: The analysis population includes all subjects for whom not more than 2 blood samples for BCD-085 assay were missing or unevaluable, and for whom no violations of blood sampling schedule were reported. Results of PK parameters consider in Cohort 1 and 2 together since the same dose were injected.
To assess the Tmax following single SC administer regardless of the cohort
Outcome measures
| Measure |
Cohort 1 + Cohort 2
n=4 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.05 mg/kg.
|
Cohort 3
n=2 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.25 mg/kg.
|
Cohort 4
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.825 mg/kg.
|
Cohort 5
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.25 mg/kg.
|
Cohort 6
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.75 mg/kg.
|
Cohort 7
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 2.25 mg/kg.
|
Cohort 8
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.
|
Cohort 8
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.
|
|---|---|---|---|---|---|---|---|---|
|
Time of Maximum Concentration of BCD-085 After Single Subcutaneous Injection
|
252.000 hours
Interval 168.0 to 336.0
|
168.000 hours
Interval 168.0 to 168.0
|
168.000 hours
Interval 168.0 to 168.0
|
72.000 hours
Interval 72.0 to 72.0
|
48.000 hours
Interval 48.0 to 72.0
|
168.000 hours
Interval 48.0 to 168.0
|
168.000 hours
Interval 168.0 to 336.0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 56 daysPopulation: The analysis population includes all subjects for whom not more than 2 blood samples for BCD-085 assay were missing or unevaluable, and for whom no violations of blood sampling schedule were reported. Results of PK parameters consider in Cohort 1 and 2 together since the same dose were injected.
Outcome measures
| Measure |
Cohort 1 + Cohort 2
n=4 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.05 mg/kg.
|
Cohort 3
n=2 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.25 mg/kg.
|
Cohort 4
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.825 mg/kg.
|
Cohort 5
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.25 mg/kg.
|
Cohort 6
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.75 mg/kg.
|
Cohort 7
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 2.25 mg/kg.
|
Cohort 8
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.
|
Cohort 8
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.
|
|---|---|---|---|---|---|---|---|---|
|
Half-life of BCD-085 After Single Subcutaneous Injection
|
425.15 hours
Interval 400.2 to 434.86
|
378.78 hours
Interval 349.56 to 408.01
|
370.13 hours
Interval 342.18 to 381.97
|
362.78 hours
Interval 354.71 to 387.87
|
428.42 hours
Interval 410.12 to 448.61
|
370.70 hours
Interval 363.15 to 387.85
|
375.76 hours
Interval 335.11 to 383.68
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 56 daysPopulation: The analysis population includes all subjects for whom not more than 2 blood samples for BCD-085 assay were missing or unevaluable, and for whom no violations of blood sampling schedule were reported. Results of PK parameters consider in Cohort 1 and 2 together since the same dose were injected.
Outcome measures
| Measure |
Cohort 1 + Cohort 2
n=4 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.05 mg/kg.
|
Cohort 3
n=2 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.25 mg/kg.
|
Cohort 4
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.825 mg/kg.
|
Cohort 5
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.25 mg/kg.
|
Cohort 6
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.75 mg/kg.
|
Cohort 7
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 2.25 mg/kg.
|
Cohort 8
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.
|
Cohort 8
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.
|
|---|---|---|---|---|---|---|---|---|
|
Constant of Elimination of BCD-085 After Single Subcutaneous Injection
|
0.002 hours^-1
Standard Deviation 0.000
|
0.002 hours^-1
Standard Deviation 0.000
|
0.002 hours^-1
Standard Deviation 0.000
|
0.002 hours^-1
Standard Deviation 0.000
|
0.002 hours^-1
Standard Deviation 0.000
|
0.002 hours^-1
Standard Deviation 0.000
|
0.002 hours^-1
Standard Deviation 0.000
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 56 daysPopulation: The analysis population includes all subjects for whom not more than 2 blood samples for BCD-085 assay were missing or unevaluable, and for whom no violations of blood sampling schedule were reported. Results of PK parameters consider in Cohort 1 and 2 together since the same dose were injected.
Outcome measures
| Measure |
Cohort 1 + Cohort 2
n=4 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.05 mg/kg.
|
Cohort 3
n=2 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.25 mg/kg.
|
Cohort 4
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.825 mg/kg.
|
Cohort 5
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.25 mg/kg.
|
Cohort 6
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.75 mg/kg.
|
Cohort 7
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 2.25 mg/kg.
|
Cohort 8
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.
|
Cohort 8
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.
|
|---|---|---|---|---|---|---|---|---|
|
Clearance of BCD-085 After Single Subcutaneous Injection
|
6.18 mL/h
Standard Deviation 2.16
|
10.25 mL/h
Standard Deviation 1.81
|
8.80 mL/h
Standard Deviation 1.04
|
8.75 mL/h
Standard Deviation 2.63
|
16.05 mL/h
Standard Deviation 2.36
|
12.29 mL/h
Standard Deviation 1.43
|
11.45 mL/h
Standard Deviation 1.81
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: day 1Population: The safety analysis will include all subjects received BCD-085.
The study subject assesses how painful was the injection. Assessment is performed by filling out a special 10-score visual analogue scale (VAS) immediately after the injection is done. The 0 score refers to no pain, the score 10 refers to the highest, almost unbearable pain. The pain was assessed after a single injection.
Outcome measures
| Measure |
Cohort 1 + Cohort 2
n=1 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.05 mg/kg.
|
Cohort 3
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.25 mg/kg.
|
Cohort 4
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.825 mg/kg.
|
Cohort 5
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.25 mg/kg.
|
Cohort 6
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.75 mg/kg.
|
Cohort 7
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 2.25 mg/kg.
|
Cohort 8
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.
|
Cohort 8
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.
|
|---|---|---|---|---|---|---|---|---|
|
Mean Pain Score by VAS Assessment During Injection of BCD-085
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 56 daysPopulation: The analysis population includes subjects who received any dose of BCD-085 subcutaneously.
Outcome measures
| Measure |
Cohort 1 + Cohort 2
n=1 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.05 mg/kg.
|
Cohort 3
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.25 mg/kg.
|
Cohort 4
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.825 mg/kg.
|
Cohort 5
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.25 mg/kg.
|
Cohort 6
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.75 mg/kg.
|
Cohort 7
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 2.25 mg/kg.
|
Cohort 8
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.
|
Cohort 8
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.
|
|---|---|---|---|---|---|---|---|---|
|
Total Frequency of AE/SAE
Total frequency of AEs
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Total Frequency of AE/SAE
Total frequency of SAEs
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 56 daysPopulation: Safety population included all subjects who received at least one injection of the study drug
Outcome measures
| Measure |
Cohort 1 + Cohort 2
n=1 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.05 mg/kg.
|
Cohort 3
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.25 mg/kg.
|
Cohort 4
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.825 mg/kg.
|
Cohort 5
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.25 mg/kg.
|
Cohort 6
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.75 mg/kg.
|
Cohort 7
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 2.25 mg/kg.
|
Cohort 8
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.
|
Cohort 8
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.
|
|---|---|---|---|---|---|---|---|---|
|
Frequency of Local Reactions
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 56 daysPopulation: The safety population included all subjects who received at least one injection of the study drug
Outcome measures
| Measure |
Cohort 1 + Cohort 2
n=1 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.05 mg/kg.
|
Cohort 3
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.25 mg/kg.
|
Cohort 4
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.825 mg/kg.
|
Cohort 5
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.25 mg/kg.
|
Cohort 6
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.75 mg/kg.
|
Cohort 7
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 2.25 mg/kg.
|
Cohort 8
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.
|
Cohort 8
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.
|
|---|---|---|---|---|---|---|---|---|
|
Frequency of Grade 3-4 AEs
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 56 daysPopulation: The safety population included all subjects who received at least one injection of the study drug
Outcome measures
| Measure |
Cohort 1 + Cohort 2
n=1 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.05 mg/kg.
|
Cohort 3
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.25 mg/kg.
|
Cohort 4
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.825 mg/kg.
|
Cohort 5
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.25 mg/kg.
|
Cohort 6
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.75 mg/kg.
|
Cohort 7
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 2.25 mg/kg.
|
Cohort 8
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.
|
Cohort 8
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.
|
|---|---|---|---|---|---|---|---|---|
|
Frequency of Early Discontinuation Due to AE
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: day 56Population: Immunogenicity was evaluated in all volunteers who received the drug administration, and who had both samples, available for analysis. Volunteer from Cohort 3 had early withdrawal, so he did not have a second sample for the study. Thus, the total number of volunteers for immunogenicity assessment was 21.
Outcome measures
| Measure |
Cohort 1 + Cohort 2
n=1 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.05 mg/kg.
|
Cohort 3
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.25 mg/kg.
|
Cohort 4
n=2 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.825 mg/kg.
|
Cohort 5
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.25 mg/kg.
|
Cohort 6
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.75 mg/kg.
|
Cohort 7
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 2.25 mg/kg.
|
Cohort 8
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.
|
Cohort 8
n=3 Participants
This cohort includes subjects who received the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.
|
|---|---|---|---|---|---|---|---|---|
|
Frequency of Binding Antibodies to BCD-85 Formation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Cohort no.1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort no.2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort no.3
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort no.4
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort no.5
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort no.6
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort no.7
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort no.8
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort no.1
n=1 participants at risk
This cohort includes just one subject who received the maximum safe starting dose of BCD-085 (0.05 mg/kg) subcutaneously.
|
Cohort no.2
n=3 participants at risk
This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.05 mg/kg.
|
Cohort no.3
n=3 participants at risk
This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.25 mg/kg.
|
Cohort no.4
n=3 participants at risk
This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.825 mg/kg.
|
Cohort no.5
n=3 participants at risk
This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.25 mg/kg.
|
Cohort no.6
n=3 participants at risk
This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.75 mg/kg.
|
Cohort no.7
n=3 participants at risk
This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 2.25 mg/kg.
|
Cohort no.8
n=3 participants at risk
This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.
|
|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.00%
0/1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
Other adverse events
| Measure |
Cohort no.1
n=1 participants at risk
This cohort includes just one subject who received the maximum safe starting dose of BCD-085 (0.05 mg/kg) subcutaneously.
|
Cohort no.2
n=3 participants at risk
This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.05 mg/kg.
|
Cohort no.3
n=3 participants at risk
This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.25 mg/kg.
|
Cohort no.4
n=3 participants at risk
This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.825 mg/kg.
|
Cohort no.5
n=3 participants at risk
This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.25 mg/kg.
|
Cohort no.6
n=3 participants at risk
This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.75 mg/kg.
|
Cohort no.7
n=3 participants at risk
This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 2.25 mg/kg.
|
Cohort no.8
n=3 participants at risk
This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.
|
|---|---|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
Elevated ALT
|
100.0%
1/1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Hepatobiliary disorders
Elevated AST
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.00%
0/1
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place