A Phase 1 Pharmacokinetic Bioequivalence Study of DMB-3113 and Adalimumab in Healthy Japanese Adult Male Subjects

Sponsor
Meiji Seika Pharma Co., Ltd.
Study ID
NCT02927353
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteer

Eligibility Criteria

Sex
MALE
Age
20 Years - 39 Years
Healthy Volunteers
Accepted

Interventions

  • DMB-3113 — DRUG
    subcutaneously injected in a single dose of 40 mg.
  • Adalimumab — DRUG
    subcutaneously injected in a single dose of 40 mg.

Study Details

To determine the pharmacokinetic bioequivalence of DMB-3113 and adalimumab and to confirm the safety of the study drug in healthy Japanese adult male subjects

Key Dates

Start date
Aug 31, 2016
Status verified
Jun 2016
Primary completion
Jan 17, 2017
Completion
Jan 17, 2017

Study Design

Enrollment
180 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: DMB-3113
    adalimumab biosimilar
  • Active Comparator: adalimumab
    adalimumab

Primary Outcome Measure

Area under the serum concentration-time curve (AUC) from 0 to final sampling time point [ Time Frame: Day 1 to Day 71 ]

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