NCT02912247

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

A Open, Randomized, Single-dose, Comparative Bioequivalency and Safety Study of Human Recombinant Anti-tumor Necrosis Factor Alpha Monoclonal Antibody Injection and Adalimumab in Chinese Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 183 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

This is a comparative, open, randomized clinical study. The purpose of the study is to demonstrate that human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection is equivalent to adalimumab in terms of pharmacokinetics and safety after single subcutaneous injection in Chinese healthy volunteers.The study will enroll 180 healthy volunteers, who will be randomized into 2 groups.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection	human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection, 40mg,subcutaneous injection,once
DRUG	adalimumab	adalimumab, 40mg,subcutaneous injection,once

Timeline

• Start date: 2016-10-27
• Primary completion: 2017-09-22
• Completion: 2017-09-22
• First posted: 2016-09-23
• Last updated: 2019-03-07