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

• Status: Completed
• Trial end date: 2017-09-22
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
• Treatments: Adalimumab; Antibodies; Antibodies, Monoclonal; Immunoglobulins

Criteria

Inclusion Criteria:

1. Male, age between 18 and 55;

2. Body weight≥50kg and body mass index(BMI) within the range 19 to 28 kg/m2;

3. 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:

1. History of adalimumab treatment;

2. History of relevant allergy/hypersensitivity(including allergy to the study drug or its ingredient );

3. Participation in another interventional trial within 3 months prior to administration of the study drug;

4. Blood donation(more than 200 mL within 12 weeks prior to administration of the study drug);

5. Use of any drugs(including traditional Chinese medicine) within 2 weeks or at least 5 half-lives(whichever is longer) prior to administration;

6. 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;

7. Abnormal significant clinically chest radiograph, ECG, or laboratory examinations at screening and Baseline, judged by the investigators;

8. History of opportunistic infection(s)(such as: herpes zoster, mycoplasma, Pneumocystis carinii, histoplasma, Aspergillus, mycobacterium) within 6 months prior to screening;

9. 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;

10. Tuberculosis(TB) history, or suspected clinically TB(including but not limited to:

pulmonary tuberculosis, lymphoid tuberculosis, tuberculous pleurisy), or a positive Tuberculosis spot test;

11. Positive serology for human immunodeficiency virus(HIV) antibody;

12. Positive serology for hepatitis C virus antibody;

13. Active or chronic hepatitis B virus infection, such as positive hepatitis B virus surface antigen;

14. History of organ transplant(except for corneal transplantation≥3 months prior to Screening);

15. Known immunodeficiency history;

16. Use a live vaccine within 3 months prior to administration;

17. Alcohol or drug abuse within 12 months prior to Screening; unwilling/inability to refrain from alcohol from 72 hours prior to administration and until during the trial period;

18. Unwilling to use adequate contraception(such as condoms) during the study period;

19. Evidence suggests presence of clinically significant hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, hematologic, or neurologic abnormality;

20. Mentally impaired;

21. Disabilities, bed rest, wheelchair dependent, or lack of activity of daily life;

22. Subjects who are unsuited to the study for any reason, judged by the investigators.