Psoriatic arthritis/Rheumatoid Arthritis
Conditions
Interventions
Experimental group:BAT2506 injection, 50mg, subcutaneous injection
Control group:Simponi, 50mg, subcutaneous injection
Sponsors
First Hospital of Jilin University
Eligibility
Sex/Gender
Male
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1) Signed the Inform Consent Form and fully understood the trial conduction, procedure and potential adverse reactions before entering the trial; 2) Willing and able to follow the visits, treatments specified in this study; 3) Subjects (including their partners) who are willing to refrain from pregnancy, sperm donation and take effective contraceptive method in the future 6 months (i.e. 6 months after study medication); 4) Healthy male subjects at the ages of 18 and 50 years; BMI between 18 and 28 kg/m2 (inclusive for both) and body weight between 50 and 80 kg (inclusive for both); 5) Physical examinations and vital signs are normal or abnormal without clinical significance; 6) Abdominal color Doppler ultrasound, laboratory tests, etc. are normal or abnormal without clinical significance.
Exclusion criteria
Exclusion criteria: 1. Daily smoking amount of >5 cigarettes within 3 months prior to the trial; 2. Any current or history of severe allergic reaction to foods or drugs and History of allergy to study products; 3. Having a history of alcoholism (14 units of alcohol per week: 1 unit= 285 mL beer, or 25 mL spirit, or 100mL wine); 4. Having donated blood within 3 months prior to screening, or planning to donate blood during the study; 5. Having severe injuries or surgery or fractures within 4 weeks before enrollment,or to receive surgery during the study; 6. Having clinically significantclinical history abnormalities or other clinically indicated diseases (including but not limited to gastrointestinal, renal, liver, neurological, hematological, endocrine, tumor, lung, immune, mental or cardiovascular diseases); 7. Having malignant tumor (excluding basal cell carcinoma who has undergone resection); 8. Having clinically significant chronic or acute infections at screening/incorporation; or active infections,Includes acute and chronic infections as well as local infections (bacteria, viruses, parasites, fungi or other opportunities) Sexually infected pathogen); 9. Having a history of tuberculosis or latent tuberculosis or clinical manifestations suspected of being tuberculosis(including But not limited to tuberculosis); 10. Having been exposed to tuberculosis or/and suspected tuberculosis symptoms and/or signs within 3 months before screening; 11. Having used simponi,or any anti-tumor necrosis factor (TNF-a) biologic preparation or any biological products within 6 months before enrollment or monoclonal antibodies within a month; 12. Having used drugs within 30 days before enrollment (including but not limited to prescription drugs, Chinese medicine, non-prescription drugs); 13. Having participated in other drug clinical trials within 3 months before enrollment; 14. Having vaccinated active / attenuated vaccine within 12 weeks before screening or planned to vaccinate active /attenuated vaccine the during the study; 15. Having a history of hypertension or systolic blood pressure = 140 mmHg, or diastolic blood pressure = at screening/inclusion90 mmHg, and it is judged abnormalities with clinical significance; 16. Electrocardiogram (ECG) examination abnormalities with clinical significance;; 17. Having positive detection of golimumab anti-drug antibody (ADA) during screening; 18. Hepatitis B surface antigen positive during screening period [or hepatitis B surface antigen negative and meet the following three items at the same time:Hepatitis B core antibody positive, hepatitis B surface antibody negative, hepatitis B virus deoxynucleotide nucleic acid (HBV DNA) quantifies over the normal range]; or hepatitis C virus (HCV) antibodies, Human immunodeficiency virus (HIV) antibody, treponema pallidum antibody positive; 19. Chest orthotopic examination abnormalities with clinical significance; 20. Tuberculosis enzyme-linked immunospot assay (T-SPOT. TB) positive test, 21. Having any alcoholic products within 24 hours prior to the use of the study drug; 22. A drug abuse test positive or a history of drug abuse over the past five years; 23. Ineligible subjects based on investigator's judgement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-t;Cmax; | — |
Secondary
| Measure | Time frame |
|---|---|
| immunogenicity;AE; | — |
Countries
China
Contacts
Public ContactYan-Hua Ding
First Hospital of Jilin University
Outcome results
None listed