A Study Of CinnoRA (Adalimumab-CinnaGen) And Adalimumab (Humira) In Healthy Subjects

Sponsor
Cinnagen
Study ID
NCT03273192
Phase
PHASE1
Status
Completed

Conditions

  • Bioequivalence
  • Phase 1

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Adalimumab — DRUG
    A single 40-mg dose of Adalimumab is administered subcutaneously to all the subjects.

Study Details

This study aims to demonstrate pharmacokinetic (PK) similarity of biosimilar candidate CinnoRA® relative to adalimumab reference product (Humira®) and evaluate safety and tolerability of CinnoRA®, in a parallel fashion in healthy volunteers after administration of a single dose (40 mg) of adalimumab. The primary objective of this study is to demonstrate that the PK of CinnoRA® is similar to its originator, Humira®, as assessed by the area under the serum concentration time curve (AUC) from time 0 extrapolated to infinity (AUCinf) and the Cmax. The secondary objectives of the study are: * To further compare the PK of CinnoRA® and Humira®. * To assess the safety of CinnoRA®.

Key Dates

Start date
Oct 22, 2016
Status verified
Sep 2018
Primary completion
Aug 6, 2017
Completion
Aug 6, 2017

Study Design

Enrollment
74 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: CinnaGen adalimumab
    CinnoRA® (adalimumab auto-injector devices produced by CinnaGen Company) 40 mg/0.8 ml in auto-injector devices A single 40-mg dose of Adalimumab was subcutaneously administered to healthy subjects.
  • Active Comparator: AbbVie adalimumab
    Humira® (adalimumab auto-injector devices produced by AbbVie Company) 40 mg/0.8 ml in auto-injector devices A single 40-mg dose of Adalimumab was subcutaneously administered to healthy subjects.

Primary Outcome Measure

Area under the concentration-time curve from time zero to infinity (AUCinf) [ Time Frame: 71 days ]

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