NCT07181694View on ClinicalTrials.gov

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

PHASE1RecruitingINTERVENTIONAL
Enrollment

444

Participants

Timeline

Start Date

March 12, 2025

Primary Completion Date

November 30, 2025

Study Completion Date

November 30, 2025

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

Trial Locations (4)

119435

RECRUITING

I.M. Sechenov First Moscow State Medical University, Moscow

194156

RECRUITING

"LLC X7 Clinical Research", Saint Petersburg

196143

RECRUITING

"LLC Research Center Eco-Safety", Saint Petersburg

199178

RECRUITING

"LLC X7 Clinical Research", Saint Petersburg

Sponsors

Lead Sponsor

Biocad
All Listed Sponsors
lead

Biocad

INDUSTRY

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 | Biotech Hunter | Biotech Hunter