Comparative Clinical Study of Pharmacokinetics, Tolerance and Safety of BCD-057 and Humira in Healthy Volunteers

Sponsor
Biocad
Study ID
NCT02395055
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Adalimumab (BCD-057) — DRUG
    Adalimumab is a monoclonal antibody against tumor necrosis factor alpha
  • Adalimumab (Humira) — DRUG
    Adalimumab is a monoclonal antibody against tumor necrosis factor alpha

Study Details

This clinical study is a phase 1 study which carried out to establish the pharmacokinetic equivalence and equal safety and tolerability profile of BCD-057 (adalimumab biosimilar candidate manufactured by CJSC BIOCAD, Russia) and Humira when used as a single subcutaneous injection in healthy volunteers.

Key Dates

Start date
Jun 30, 2015
Status verified
Oct 2021
Primary completion
Oct 31, 2015
Completion
Oct 31, 2015

Study Design

Enrollment
94 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: BCD-057 group
    BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
  • Active Comparator: Humira group
    Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.

Primary Outcome Measure

Maximum Concentration of Adalimumab After Single SC Injection of BCD-057/Humira [ Time Frame: 0, 6, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-dose ]

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