Comparison of the Safety and PK of SYN060 to Humira® in Healthy Adult Subjects

Sponsor
Synermore Biologics Co., Ltd.
Study ID
NCT03254810
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • SYN060 — BIOLOGICAL
    a single subcutaneous 0.57 mg/kg dose of SYN060
  • Adalimumab North American source — BIOLOGICAL
    a single subcutaneous 0.57 mg/kg dose of adalimumab (Humira®) reference product from North American source
  • Adalimumab European source — BIOLOGICAL
    a single subcutaneous 0.57 mg/kg dose of adalimumab (Humira®) reference product from European source

Study Details

This is a single site, parallel randomized, double blinded comparison of the safety, pharmacokinetics, and immunogenicity of a single 0.57 mg/kg dose of SYN060 to a single 0.57 mg/kg dose of adalimumab (Humira®) reference product from North American and European sources. The study is open to healthy individuals on no medications that might confound the results of this safety study.

Key Dates

Start date
Sep 26, 2017
Status verified
Nov 2018
Primary completion
Jul 17, 2018
Completion
Jul 17, 2018

Study Design

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

Arms

  • Experimental: SYN060
    a single 0.57 mg/kg dose of SYN060
  • Active Comparator: Adalimumab North American source
    a single 0.57 mg/kg dose of adalimumab from North American source
  • Active Comparator: Adalimumab European source
    a single 0.57 mg/kg dose of adalimumab from European source

Primary Outcome Measure

AUC0-last (area under the concentration-time curve from time zero to the last non-zero concentration) and AUC0-inf (area under the concentration-time curve from time zero to infinity) [ Time Frame: 85 days ]

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