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The Study of PK, PD, Safety of Multiple Intravenous Injections of BCD-066 and Aranesp in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT03693950
Recruitment Status : Completed
First Posted : October 3, 2018
Results First Posted : July 1, 2019
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
Biocad

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Other
Condition Healthy
Interventions Biological: BCD-066
Biological: Aranesp
Enrollment 57
Recruitment Details  
Pre-assignment Details  
Arm/Group Title BCD-066 1 µg/kg Aranesp 1 µg/kg
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 29 28
Completed 28 28
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title BCD-066 1 µg/kg Aranesp 1 µg/kg Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 28 28 56
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 28 participants 28 participants 56 participants
24
(22 to 31)
27.50
(24 to 31)
27.50
(24 to 31)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 28 participants 56 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
28
 100.0%
28
 100.0%
56
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 28 participants 56 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
28
 100.0%
28
 100.0%
56
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title AUC(0-72)
Hide Description 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
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BCD-066 1 µg/kg Aranesp 1 µg/kg
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 28 28
Median (Inter-Quartile Range)
Unit of Measure: pg/ml·h
328215.65
(275530.49 to 401053.38)
290827.12
(252607.47 to 349760.35)
2.Secondary Outcome
Title Cmax
Hide Description The maximum concentration of darbepoetin alfa in the serum after the first and the fourth IV injection of BCD-066 or Aranesp®
Time Frame 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-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BCD-066 1 µg/kg Aranesp 1 µg/kg
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 28 28
Median (Inter-Quartile Range)
Unit of Measure: pg/ml
18365.15
(16861.5 to 22490)
17003.25
(13716.6 to 19664.2)
3.Secondary Outcome
Title
Hide Description The elimination half-life
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BCD-066 1 µg/kg Aranesp 1 µg/kg
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 28 28
Median (Inter-Quartile Range)
Unit of Measure: hours
12.53
(11.334 to 13.235)
12.69
(11.47 to 13.555)
4.Secondary Outcome
Title AUC(0-∞)
Hide Description The total area under the concentration curve from 0 to infinity
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BCD-066 1 µg/kg Aranesp 1 µg/kg
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 28 28
Median (Inter-Quartile Range)
Unit of Measure: pg/ml·h
331725.75
(276986.83 to 404075.52)
296135.38
(260610.81 to 356012.29)
5.Secondary Outcome
Title Tmax
Hide Description The time to maximum drug concentration in the serum
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BCD-066 1 µg/kg Aranesp 1 µg/kg
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 28 28
Median (Inter-Quartile Range)
Unit of Measure: hours
0.125
(0.083 to 0.25)
0.083
(0.083 to 0.25)
6.Secondary Outcome
Title Kel
Hide Description The elimination constant: kel=1/MRT, where MRT is median residence time: MRT=AUMC(0-72)/AUC(0-72)
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BCD-066 1 µg/kg Aranesp 1 µg/kg
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 28 28
Median (Inter-Quartile Range)
Unit of Measure: fraction of drug per hour
0.055
(0.052 to 0.06)
0.055
(0.051 to 0.06)
7.Secondary Outcome
Title CL
Hide Description The total clearance
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BCD-066 1 µg/kg Aranesp 1 µg/kg
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 28 28
Median (Inter-Quartile Range)
Unit of Measure: ml/h
230.358
(210.737 to 275.827)
243.055
(197.849 to 299.107)
Time Frame 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)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BCD-066 1 µg/kg Aranesp 1 µg/kg
Hide Arm/Group Description

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

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

All-Cause Mortality
BCD-066 1 µg/kg Aranesp 1 µg/kg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)      0/28 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
BCD-066 1 µg/kg Aranesp 1 µg/kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/28 (0.00%)      0/28 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
BCD-066 1 µg/kg Aranesp 1 µg/kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/28 (17.86%)      16/28 (57.14%)    
Blood and lymphatic system disorders     
monocytes count increase   2/28 (7.14%)  1/28 (3.57%) 
thrombocytes count increase   2/28 (7.14%)  5/28 (17.86%) 
Hematocrit decrease   0/28 (0.00%)  3/28 (10.71%) 
Hemoglobin decrease   0/28 (0.00%)  1/28 (3.57%) 
WBC decrease   0/28 (0.00%)  2/28 (7.14%) 
Neutrophis count decrease   1/28 (3.57%)  3/28 (10.71%) 
RBC decrease   0/28 (0.00%)  1/28 (3.57%)  2
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Yulia Linkova Medical Director
Organization: BIOCAD
Phone: +7 (495) 992 66 28 ext. 930
EMail: linkova@biocad.ru
Layout table for additonal information
Responsible Party: Biocad
ClinicalTrials.gov Identifier: NCT03693950     History of Changes
Other Study ID Numbers: BCD-066-3
First Submitted: October 1, 2018
First Posted: October 3, 2018
Results First Submitted: October 8, 2018
Results First Posted: July 1, 2019
Last Update Posted: July 1, 2019