Comparative Clinical Trial to Evaluate Bioequivalency and Safety of Monoclonal Antibody Injection and Adalimumab in Chinese Healthy Volunteers

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT02912247
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection — DRUG
    human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection, 40mg,subcutaneous injection,once
  • adalimumab — DRUG
    adalimumab, 40mg,subcutaneous injection,once

Study Details

This clinical study is a phase 1 study which carried out to establish the pharmacokinetic equivalence and equal safety of human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection and Adalimumab when used as a single subcutaneous injection in healthy volunteers.

Key Dates

Start date
Oct 27, 2016
Status verified
Jun 2018
Primary completion
Sep 22, 2017
Completion
Sep 22, 2017

Study Design

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

Arms

  • Experimental: monoclonal antibody injection
    human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection 40mg administered subcutaneously once
  • Active Comparator: adalimumab
    adalimumab 40mg administered subcutaneously once

Primary Outcome Measure

Area under the concentration-time curve from time zero to the last quantifiable concentration(AUClast) [ Time Frame: 71days ]

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