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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

NCT07181694 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 444

Last updated 2025-10-03

No results posted yet for this study

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.

Conditions

  • Healthy Adult Male

Interventions

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

Sponsors & Collaborators

  • Biocad

    lead INDUSTRY

Principal Investigators

  • Arina V Zinkina-Orikhan · Biocad

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-12
Primary Completion
2025-11-30
Completion
2025-11-30

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07181694 on ClinicalTrials.gov