Comparative Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of Adalimumab in Healthy Subjects

Sponsor
Turgut İlaçları A.Ş.
Study ID
NCT04439929
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • TUR01 — BIOLOGICAL
    Administered as a single 40 mg, subcutaneous dose
  • Adalimumab-EU — BIOLOGICAL
    Administered as a single 40 mg, subcutaneous dose

Study Details

This is a randomized, double-blind, two-arm, parallel group, single-dose study to demonstrate pharmacokinetic, safety, tolerability and immunogenicity similarity of biosimilar candidate TUR01 to EU-sourced Humira® in healthy participants after administration of adalimumab.

Key Dates

First listed
Jun 19, 2020
Start date
Jul 17, 2019
Status verified
Jun 2020
Primary completion
Jan 16, 2020
Completion
Jan 16, 2020

Study Design

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

Arms

  • Experimental: Adalimumab-TUR01
  • Active Comparator: Adalimumab-EU

Primary Outcome Measure

Area under the concentration-time curve from time 0 to infinity (AUCinf) [ Time Frame: Day 1 - Day 71 ]

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