Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT02731469
Brief 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
Detailed Description:
BCD-131 is novel drug product of pegylated darbepoetin alfa.
Clinical trial BCD-131-1 will be conducted in two stages:
Stage I is an open-label, non-randomized clinical study of pharmacokinetics, pharmacodynamics, tolerability, safety and immunogenicity of BCD-131 given to healthy volunteers at ascending doses (Phase 1, a traditional "3+3" design).
Also, the PK and PD parameters of the closest analogues of BCD-131 (Mircera and Aranesp) given as subcutaneous injections at therapeutic doses will be evaluated.
Stage II aims to further evaluate pharmacokinetics, pharmacodynamics and safety of subcutaneous and intravenous injections of BCD-131 at a dose which ensures PD effects similar to those of the closest analogues (Mircera, Aranesp) given as subcutaneous injections at therapeutic doses.
Study:
NCT02731469
Study Brief:
Protocol Section:
NCT02731469