CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 57 enrolled
Drug / intervention
BCD-066 +1 morebiological
Likely dose
BCD-066 1 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03693950
NCT03693950Phase 1Completed
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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

Biocad·interventional·Posted Oct 3, 2018·Updated Apr 21, 2020

In Brief

A Phase 1 clinical trial evaluating BCD-066 and Aranesp for Healthy. Completed, enrolled 57 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesRussia
Collaborators--

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 3, 2018
Enrollment StartMar 28, 2017
Primary CompletionJul 3, 2017
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 7.7 years ago

Interventions

BCD-066biological

BCD-066 will be administered once a week intravenously in a dose 1 µg/kg

Aranespbiological

Aranesp will be administered once a week intravenously in a dose 1 µg/kg