Trials / Completed
CompletedNCT03693950
The Study of PK, PD, Safety of Multiple Intravenous Injections of BCD-066 and Aranesp in Healthy Volunteers
A Double-blind, Randomized, Controlled Clinical Study of the Pharmacokinetics, Pharmacodynamics, Tolerability, and Safety of Multiple Intravenous Injections of BCD-066 and Aranesp® in Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 57 (actual)
- Sponsor
- Biocad · Industry
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
BCD-066 is a darbepoetin alfa. Clinical study BCD-066-3 is a double-blind controlled, randomized, parallel-group study of the pharmacokinetics, pharmacodynamics, tolerability, and safety of multiple intravenous injections of BCD-066 and Aranesp®. The purpose of the study is to confirm the equivalent pharmacokinetics, pharmacodynamics, safety, and tolerability of multiple IV injections of BCD-066 and Aranesp® in healthy volunteers.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | BCD-066 | BCD-066 will be administered once a week intravenously in a dose 1 µg/kg |
| BIOLOGICAL | Aranesp | Aranesp will be administered once a week intravenously in a dose 1 µg/kg |
Timeline
- Start date
- 2017-03-28
- Primary completion
- 2017-07-03
- Completion
- 2017-07-03
- First posted
- 2018-10-03
- Last updated
- 2020-04-21
- Results posted
- 2019-07-01
Locations
1 site across 1 country: Russia
Source: ClinicalTrials.gov record NCT03693950. Inclusion in this directory is not an endorsement.