Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 12:03 AM
Study NCT ID:
NCT07181694
Status:
RECRUITING
Last Update Posted:
2025-10-03
First Post:
2025-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Pharmacokinetics, Safety, and Immunogenicity of BCD-057 100 mg/mL, BCD-057 50 mg/mL, and Humira 100 mg/mL in Healthy Subjects
Sponsor:
Biocad
Organization:
Study Overview
Official Title:
A Double-Blind, Comparative, Randomized Clinical Study of the Pharmacokinetics, Safety, and Immunogenicity of Single Subcutaneous Doses of BCD 057 100 mg/mL, BCD-057 50 mg/mL, and Humira 100 mg/mL in Healthy Subjects
Status:
RECRUITING
Status Verified Date:
2025-09
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:
The aim of this study is to establish comparability of pharmacokinetic parameters and similarity of the safety and immunogenicity profiles of single subcutaneous doses of BCD 057 100 mg/mL and BCD-057 50 mg/mL, as well as BCD-057 100 mg/mL and Humira 100 mg/mL, in healthy subjects. The study is conducted in a population of healthy male subjects aged 18-45 years inclusive at the time of signing the ICF, with a body mass index in the range of 18.5 to 30.0 kg/m2.
Detailed Description:
The study includes following periods:
* Screening (not more than 14 days)
* Main period (Day 1 to Day 71)
Subjects meeting the eligibility criteria will be randomized with equal probability into one of three groups:
* ADA100 group - subjects will receive a single subcutaneous injection of BCD-057 at a dose of 40 mg/0.4 mL
* ADA50 group - subjects will receive a single subcutaneous injection of BCD-057 at a dose of 40 mg/0.8 mL
* HUM100 group - subjects will receive a single subcutaneous injection of Humira at a dose of 40 mg/0.4 mL
During randomization, subjects will be stratified by the following criterion:
* Body weight (\<75 kg or ≥75 kg)
* Screening (not more than 14 days)
* Main period (Day 1 to Day 71)
Subjects meeting the eligibility criteria will be randomized with equal probability into one of three groups:
* ADA100 group - subjects will receive a single subcutaneous injection of BCD-057 at a dose of 40 mg/0.4 mL
* ADA50 group - subjects will receive a single subcutaneous injection of BCD-057 at a dose of 40 mg/0.8 mL
* HUM100 group - subjects will receive a single subcutaneous injection of Humira at a dose of 40 mg/0.4 mL
During randomization, subjects will be stratified by the following criterion:
* Body weight (\<75 kg or ≥75 kg)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: