Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-30 @ 11:57 PM
Study NCT ID:
NCT02731469
Status:
COMPLETED
Last Update Posted:
2019-07-01
First Post:
2016-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Pharmacokinetics, Pharmacodynamics, Safety of BCD-131 Compared to Mircera and Aranesp in Healthy Volunteers
Sponsor:
Biocad
Organization:
Study Overview
Official Title:
Clinical Study of the Pharmacokinetics, Pharmacodynamics, Tolerability, Safety and Immunogenicity of BCD-131 Compared to Mircera and Aranesp in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: