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

Innovent Biologics (Suzhou) Co. Ltd.0 sites183 target enrollmentOctober 27, 2016

ConditionsHealthy

Interventionshuman recombinant anti-tumor necrosis factor alpha monoclonal antibody injection adalimumab

Drugshuman recombinant anti-tumor necrosis factor alpha monoclonal antibody injection adalimumab

Overview

Phase: Phase 1
Intervention: human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection
Conditions: Healthy
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Enrollment: 183
Primary Endpoint: Area under the concentration-time curve from time zero to the last quantifiable concentration(AUClast)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 27, 2016

End Date

September 22, 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male, age between 18 and 55;
•Body weight≥50kg and body mass index(BMI) within the range 19 to 28 kg/m2;
•To fully understanding the purpose of the study, to understand the pharmacological action of the study drugs and the possible adverse reactions; participants who are voluntary to sign the informed consent according to the Declaration of Helsinki.

Exclusion Criteria

•History of adalimumab treatment;
•History of relevant allergy/hypersensitivity(including allergy to the study drug or its ingredient );
•Participation in another interventional trial within 3 months prior to administration of the study drug;
•Blood donation(more than 200 mL within 12 weeks prior to administration of the study drug);
•Use of any drugs(including traditional Chinese medicine) within 2 weeks or at least 5 half-lives(whichever is longer) prior to administration;
•History of cluster of differentiation 4 antagonist or tumor necrosis factor alpha antagonist use, or use tumor necrosis factor antagonist(such as thalidomide) 3 months prior to administration;
•Abnormal significant clinically chest radiograph, ECG, or laboratory examinations at screening and Baseline, judged by the investigators;
•History of opportunistic infection(s)(such as: herpes zoster, mycoplasma, Pneumocystis carinii, histoplasma, Aspergillus, mycobacterium) within 6 months prior to screening;
•Known recurrent or chronic infectious disease(s) history, including but not limited to: chronic kidney infect, chronic chest infection(such as bronchiectasis), nasosinusitis, recurrent urinary tract infection, open, drainage or infected wounds of the skin;
•Tuberculosis(TB) history, or suspected clinically TB(including but not limited to: pulmonary tuberculosis, lymphoid tuberculosis, tuberculous pleurisy), or a positive Tuberculosis spot test;