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

Sponsor
Biocad
Study ID
NCT07181694
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy Adult Male

Eligibility Criteria

Sex
MALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Mar 12, 2025
Status verified
Sep 2025
Primary completion
Nov 30, 2025
Completion
Nov 30, 2025

Study Design

Enrollment
444 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: ADA100
    Subjects will receive a single subcutaneous injection of BCD-057 at a dose of 40 mg/0.4 mL
  • Active Comparator: ADA50
    Subjects will receive a single subcutaneous injection of BCD-057 at a dose of 40 mg/0.8 mL
  • Active Comparator: HUM100
    Subjects will receive a single subcutaneous injection of Humira at a dose of 40 mg/0.4 mL

Primary Outcome Measure

AUC(0-∞) [ Time Frame: Before drug administration and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours after drug administration ]

Central Contacts

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