Overview

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

Status:
RECRUITING

Trial end date:
2025-11-01

Target enrollment:

Participant gender:

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.

Phase:

PHASE1

Details

Lead Sponsor:

Biocad

Treatments:

Adalimumab