Trial Outcomes & Findings for The Study of PK, PD, Safety of Multiple Intravenous Injections of BCD-066 and Aranesp in Healthy Volunteers (NCT NCT03693950)
NCT ID: NCT03693950
Last Updated: 2020-04-21
Results Overview
The area concentration curve for darbepoetin alfa from injection to 72 h (AUC(0-72) after the first and the fourth IV injection of BCD-066 or Aranesp
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
57 participants
Primary outcome timeframe
5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-dose
Results posted on
2020-04-21
Participant Flow
Participant milestones
| Measure |
BCD-066 1 µg/kg
Healthy volunteers will receive BCD-066 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.
BCD-066: BCD-066 will be administered once a week intravenously in a dose 1 µg/kg
|
Aranesp 1 µg/kg
Healthy volunteers will receive Aranesp 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.
Aranesp: Aranesp will be administered once a week intravenously in a dose 1 µg/kg
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
28
|
|
Overall Study
COMPLETED
|
28
|
28
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
BCD-066 1 µg/kg
Healthy volunteers will receive BCD-066 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.
BCD-066: BCD-066 will be administered once a week intravenously in a dose 1 µg/kg
|
Aranesp 1 µg/kg
Healthy volunteers will receive Aranesp 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.
Aranesp: Aranesp will be administered once a week intravenously in a dose 1 µg/kg
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
The Study of PK, PD, Safety of Multiple Intravenous Injections of BCD-066 and Aranesp in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
BCD-066 1 µg/kg
n=28 Participants
Healthy volunteers will receive BCD-066 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.
BCD-066: BCD-066 will be administered once a week intravenously in a dose 1 µg/kg
|
Aranesp 1 µg/kg
n=28 Participants
Healthy volunteers will receive Aranesp 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.
Aranesp: Aranesp will be administered once a week intravenously in a dose 1 µg/kg
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
24 years
n=99 Participants
|
27.50 years
n=107 Participants
|
27.50 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-doseThe area concentration curve for darbepoetin alfa from injection to 72 h (AUC(0-72) after the first and the fourth IV injection of BCD-066 or Aranesp
Outcome measures
| Measure |
BCD-066 1 µg/kg
n=28 Participants
Healthy volunteers will receive BCD-066 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.
BCD-066: BCD-066 will be administered once a week intravenously in a dose 1 µg/kg
|
Aranesp 1 µg/kg
n=28 Participants
Healthy volunteers will receive Aranesp 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.
Aranesp: Aranesp will be administered once a week intravenously in a dose 1 µg/kg
|
|---|---|---|
|
AUC(0-72)
|
328215.65 pg/ml·h
Interval 275530.49 to 401053.38
|
290827.12 pg/ml·h
Interval 252607.47 to 349760.35
|
SECONDARY outcome
Timeframe: 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-dose post-doseThe maximum concentration of darbepoetin alfa in the serum after the first and the fourth IV injection of BCD-066 or Aranesp®
Outcome measures
| Measure |
BCD-066 1 µg/kg
n=28 Participants
Healthy volunteers will receive BCD-066 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.
BCD-066: BCD-066 will be administered once a week intravenously in a dose 1 µg/kg
|
Aranesp 1 µg/kg
n=28 Participants
Healthy volunteers will receive Aranesp 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.
Aranesp: Aranesp will be administered once a week intravenously in a dose 1 µg/kg
|
|---|---|---|
|
Cmax
|
18365.15 pg/ml
Interval 16861.5 to 22490.0
|
17003.25 pg/ml
Interval 13716.6 to 19664.2
|
SECONDARY outcome
Timeframe: 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-doseThe elimination half-life
Outcome measures
| Measure |
BCD-066 1 µg/kg
n=28 Participants
Healthy volunteers will receive BCD-066 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.
BCD-066: BCD-066 will be administered once a week intravenously in a dose 1 µg/kg
|
Aranesp 1 µg/kg
n=28 Participants
Healthy volunteers will receive Aranesp 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.
Aranesp: Aranesp will be administered once a week intravenously in a dose 1 µg/kg
|
|---|---|---|
|
T½
|
12.53 hours
Interval 11.334 to 13.235
|
12.69 hours
Interval 11.47 to 13.555
|
SECONDARY outcome
Timeframe: 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-doseThe total area under the concentration curve from 0 to infinity
Outcome measures
| Measure |
BCD-066 1 µg/kg
n=28 Participants
Healthy volunteers will receive BCD-066 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.
BCD-066: BCD-066 will be administered once a week intravenously in a dose 1 µg/kg
|
Aranesp 1 µg/kg
n=28 Participants
Healthy volunteers will receive Aranesp 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.
Aranesp: Aranesp will be administered once a week intravenously in a dose 1 µg/kg
|
|---|---|---|
|
AUC(0-∞)
|
331725.75 pg/ml·h
Interval 276986.83 to 404075.52
|
296135.38 pg/ml·h
Interval 260610.81 to 356012.29
|
SECONDARY outcome
Timeframe: 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-doseThe time to maximum drug concentration in the serum
Outcome measures
| Measure |
BCD-066 1 µg/kg
n=28 Participants
Healthy volunteers will receive BCD-066 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.
BCD-066: BCD-066 will be administered once a week intravenously in a dose 1 µg/kg
|
Aranesp 1 µg/kg
n=28 Participants
Healthy volunteers will receive Aranesp 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.
Aranesp: Aranesp will be administered once a week intravenously in a dose 1 µg/kg
|
|---|---|---|
|
Tmax
|
0.125 hours
Interval 0.083 to 0.25
|
0.083 hours
Interval 0.083 to 0.25
|
SECONDARY outcome
Timeframe: 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-doseThe elimination constant: kel=1/MRT, where MRT is median residence time: MRT=AUMC(0-72)/AUC(0-72)
Outcome measures
| Measure |
BCD-066 1 µg/kg
n=28 Participants
Healthy volunteers will receive BCD-066 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.
BCD-066: BCD-066 will be administered once a week intravenously in a dose 1 µg/kg
|
Aranesp 1 µg/kg
n=28 Participants
Healthy volunteers will receive Aranesp 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.
Aranesp: Aranesp will be administered once a week intravenously in a dose 1 µg/kg
|
|---|---|---|
|
Kel
|
0.055 fraction of drug per hour
Interval 0.052 to 0.06
|
0.055 fraction of drug per hour
Interval 0.051 to 0.06
|
SECONDARY outcome
Timeframe: 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-doseThe total clearance
Outcome measures
| Measure |
BCD-066 1 µg/kg
n=28 Participants
Healthy volunteers will receive BCD-066 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.
BCD-066: BCD-066 will be administered once a week intravenously in a dose 1 µg/kg
|
Aranesp 1 µg/kg
n=28 Participants
Healthy volunteers will receive Aranesp 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.
Aranesp: Aranesp will be administered once a week intravenously in a dose 1 µg/kg
|
|---|---|---|
|
CL
|
230.358 ml/h
Interval 210.737 to 275.827
|
243.055 ml/h
Interval 197.849 to 299.107
|
Adverse Events
BCD-066 1 µg/kg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Aranesp 1 µg/kg
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BCD-066 1 µg/kg
n=28 participants at risk
Healthy volunteers will receive BCD-066 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.
BCD-066: BCD-066 will be administered once a week intravenously in a dose 1 µg/kg
|
Aranesp 1 µg/kg
n=28 participants at risk
Healthy volunteers will receive Aranesp 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.
Aranesp: Aranesp will be administered once a week intravenously in a dose 1 µg/kg
|
|---|---|---|
|
Blood and lymphatic system disorders
monocytes count increase
|
7.1%
2/28 • AEs where collected from the first drug administration (visit 1, day 1) till the end of follow-up period (4 weeks after the last administration of the drug (day 50)
|
3.6%
1/28 • AEs where collected from the first drug administration (visit 1, day 1) till the end of follow-up period (4 weeks after the last administration of the drug (day 50)
|
|
Blood and lymphatic system disorders
thrombocytes count increase
|
7.1%
2/28 • AEs where collected from the first drug administration (visit 1, day 1) till the end of follow-up period (4 weeks after the last administration of the drug (day 50)
|
17.9%
5/28 • AEs where collected from the first drug administration (visit 1, day 1) till the end of follow-up period (4 weeks after the last administration of the drug (day 50)
|
|
Blood and lymphatic system disorders
Hematocrit decrease
|
0.00%
0/28 • AEs where collected from the first drug administration (visit 1, day 1) till the end of follow-up period (4 weeks after the last administration of the drug (day 50)
|
10.7%
3/28 • AEs where collected from the first drug administration (visit 1, day 1) till the end of follow-up period (4 weeks after the last administration of the drug (day 50)
|
|
Blood and lymphatic system disorders
Hemoglobin decrease
|
0.00%
0/28 • AEs where collected from the first drug administration (visit 1, day 1) till the end of follow-up period (4 weeks after the last administration of the drug (day 50)
|
3.6%
1/28 • AEs where collected from the first drug administration (visit 1, day 1) till the end of follow-up period (4 weeks after the last administration of the drug (day 50)
|
|
Blood and lymphatic system disorders
WBC decrease
|
0.00%
0/28 • AEs where collected from the first drug administration (visit 1, day 1) till the end of follow-up period (4 weeks after the last administration of the drug (day 50)
|
7.1%
2/28 • AEs where collected from the first drug administration (visit 1, day 1) till the end of follow-up period (4 weeks after the last administration of the drug (day 50)
|
|
Blood and lymphatic system disorders
Neutrophis count decrease
|
3.6%
1/28 • AEs where collected from the first drug administration (visit 1, day 1) till the end of follow-up period (4 weeks after the last administration of the drug (day 50)
|
10.7%
3/28 • AEs where collected from the first drug administration (visit 1, day 1) till the end of follow-up period (4 weeks after the last administration of the drug (day 50)
|
|
Blood and lymphatic system disorders
RBC decrease
|
0.00%
0/28 • AEs where collected from the first drug administration (visit 1, day 1) till the end of follow-up period (4 weeks after the last administration of the drug (day 50)
|
3.6%
1/28 • Number of events 2 • AEs where collected from the first drug administration (visit 1, day 1) till the end of follow-up period (4 weeks after the last administration of the drug (day 50)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place