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

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.

NCT Number	NCT07181694
Lead Sponsor	Biocad
Conditions	Healthy Adult Male
Enrollment	444 participants
Start Date	2025-03-12
Primary Completion	2026-02-12 (estimated)
Study Completion	2026-02-12 (estimated)
Updated on ClinicalTrials.gov	2026-07-28