CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 45 enrolled
Drug / intervention
BCD-131 +2 morebiological
Likely dose
Not stated in 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/NCT02731469
NCT02731469Phase 1Completed
CompareCT.gov

Clinical Study of the Pharmacokinetics, Pharmacodynamics, Tolerability, Safety and Immunogenicity of BCD-131 Compared to Mircera and Aranesp in Healthy Volunteers

Biocad·interventional·Posted Apr 7, 2016·Updated Jul 1, 2019

In Brief

A Phase 1 clinical trial evaluating BCD-131, Mircera®, and 1 other intervention for Reticulocyte Count. Completed, enrolled 45 participants.

Detailed Summary

BCD-131-1 is an Open-Label Clinical Study of the Pharmacokinetics, Pharmacodynamics, Tolerability, Safety and Immunogenicity of Single Ascending Doses of BCD-131 in Healthy Volunteers

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsReticulocyte Count
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 7, 2016
Enrollment StartJun 15, 2016
Primary CompletionMar 1, 2017
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 10.2 years ago

Interventions

BCD-131biological

Mircera®biological

Aranesp®biological