Phase I Study of HLX3 vs Adalimumab in Chinese Healthy Subjects

• Status: Completed
• Trial end date: 2018-09-15
• Target enrollment: 0
• Participant gender: Male

Summary

This healthy male volunteers study will evaluate 148 subjects who will receive a single sub-cutaneous dose of HLX03 （a monoclonal antibody against TNF-a, 40 mg/ 0.8 mL） or Adalimumab(Humira,China spourced,40 mg/0.8 mL injection with a single-use prefilled syringe). This study will involve sampling,pharmacokinetics, safety, tolerability and immunogenicity evaluation of drug levels following administration of HLX03 and the licensed adalimumab products.

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

Details

• Lead Sponsor: Shanghai Henlius Biotech
• Treatments: Adalimumab

Criteria

Inclusion Criteria:

1. Healthy Chinese males (age: 18~45 yrs) with contraception during and 3 months post-dose. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure, pulse, ECG, and laboratory testing.

2. BMI between 19.0 and 28.0 kg/m² and body weight between 55 kg and 80 kg.

Exclusion Criteria:

1. suffering from active or latent tuberculosis or history of tuberculosis;

2. have heart disease or a history of heart disease;

3. suffer from mental illness or psychiatric history;

4. suffering from malignant tumors and their history;

5. suffering from herpes zoster and its history;

6. suffering from epilepsy and history of epilepsy;

7. be allergic to the drugs or its components with high sensitivity or allergic reaction, detection of ADA (+);

8. patients who lost blood or donated more than 200 mL within the first 2 months before the screening;

9. major surgery performed within 30 days prior to signing ICF;

10. live vaccine inoculation or vaccination within 12 weeks of screening, or possible administration of vaccine during screening and study visits;

11. previous application of adalimumab or its biosimilars, or anti-TNF alpha drugs;

12. participating in other clinical trials within the first 3 months of the trial;

13. abnormal immune function within 4 weeks before screening;

14. the presence of invasive systemic fungal infection or other opportunistic infections within 2 months prior to screening;

15. systemic or local infection, such as the risk of sepsis and / or known active inflammation within 2 months before screening;

16. 2 months before the screening, there were severe infections in the hospital and / or the need for intravenous antibiotics;

17. 4 or more upper respiratory tract infections occurred within 6 months prior to randomization;

18. hepatitis B surface antigen (HBsAg) positive; if hepatitis B surface antigen (HBsAg) negative, hepatitis B core antibody (HBcAb) positive, peripheral blood hepatitis B virus deoxyribonucleic acid (DNA) test >0 IU/ml also ruled out;

19. hepatitis C virus (HCV) antibody positive;

20. human immunodeficiency virus (HIV) antibody positive;

21. Treponema pallidum (Treponema pallidum, TP) antibody positive;

22. anti nuclear antibody titer was 1:100 examination;

23. drug abusers, alcohol addicts;

24. , the researchers discretion of failure to follow the requirements of the program, instructions and research limitations, such as uncooperative attitude, unable to return to the Research Center for follow-up visits, or unable to complete the entire clinical study.