NCT07181694

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 444 (estimated)
• Sponsor: Biocad · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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)

Conditions

• Healthy Adult Male

Interventions

Type	Name	Description
DRUG	Adalimumab (BCD-057) 100 mg/mL	Single subcutaneous injection
DRUG	Adalimumab (BCD-057) 50 mg/mL	Single subcutaneous injection
DRUG	Adalimumab (Humira) 100 mg/mL	Single subcutaneous injection

Timeline

• Start date: 2025-03-12
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2025-09-18
• Last updated: 2025-10-03

Locations

4 sites across 1 country: Russia