drugset / Trial / NCT03693950

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

NCT03693950

Phase 1 Completed 57 enrolled Biocad
RandomizedParallel-groupDouble-blindOther

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.

Timeline

Start
2017-03-28
Primary completion
2017-07-03
Completion
2017-07-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Darbepoetin alfa Protein / enzyme biologic 1 ug/kg Intravenous

Indications

No indication recorded.