Healthy Chinese Male
Conditions
Interventions
BAT1406 injection A2 group:Subcutaneous injection of BAT1406 A2 injection
BAT1406 injection B3 group:Subcutaneous injection of BAT1406 B3 injection
Adalimumab Injection group :Subcutaneous injection of Adalimumab Injection
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Chinese male healthy subjects aged between 18 and 55 (including boundary value); 2. Body mass index is between 18.5 ~ 28 kg/m2 and weight is between 50 ~ 95kg (including boundary value); 3. Agree to adopt effective contraceptive measures (including but not limited to: sterilization, physical contraception, or abstinence) within a half year of the entire trial period and the end of the study (including but not limited to: sterilization surgery, physical contraception or abstinence); 4. Willing to sign informed consent and be willing and able to follow the inspection, treatment, laboratory examination and other related procedures specified in this study.
Exclusion criteria
Exclusion criteria: 1. General physical examination, blood routine, blood biochemical, coagulation, urine routine, chest X-ray examination or 12 guide ECG were abnormal, and were determined by the researchers to be clinically significant; 2. Medical history of heart, liver, kidney, digestive tract, nervous system, mental abnormality and metabolic abnormality are not suitable for the study; 3. History of high blood pressure, or screening/baseline systolic pressure > 140 mmHg or diastolic > 90 mmHg; 4. Now or once had a malignant tumor (excluding basal cell carcinoma); 5. There are active infections, including acute and chronic infections and local infections; 6. Tuberculosis (including but not limited to tuberculosis) in patients with tuberculosis or latent tuberculosis (including but not limited to tuberculosis), or chest X-ray shows active tuberculosis; 7. T-spot. TB gamma interferon release test positive; 8. Screening for hiv-ab positive, or HCV-Ab positive, or syphilis test positive; 9. The HBsAg was tested positive for HBsAg during screening, or the following three conditions were met: anti-hbc positive, anti-hbs negative and hbv-dna exceeded normal range; 10. Test for ever use drugs (including but not limited to, traditional Chinese medicine (TCM), non-prescription, etc.), JuMo medication time distance test to less than five half-life of drugs, or two weeks (the longer of the two shall prevail); 11. Any anti-tnf-alpha biological agents were used; 12. Use any biological agents within the first three months of the trial; 13. A biologic agent of any immunoglobulins was used in the first 1 year of the test; 14. Inoculated with active or attenuated vaccine or immunosuppressant agents within 12 weeks prior to the trial; 15. When screening, ADA was tested positive for ADA; 16. There has been a history of drug abuse or alcohol dependence in the last year; 17. Drinking more than 28 units of alcohol per week (1 unit =285ml beer or 25ml spirits or 125ml wine); 18. Drinking alcoholic beverages in the first 24 hours prior to the injection and not restricting the drinker during the testing process; 19. Smoking more than five cigarettes a day, or smoking in the first 24 hours before the injection, or not restricting smokers during the test process; 20. Participants who participated in excessive intensity of physical activity for 72 hours prior to the injection (e.g. strength training, aerobic training, football, etc.); 21. It is known that any component or protein allergy to adamuzumab injection or allergy to immunoglobulins and other drugs has a history of major allergy; 22. During the first 3 months of the trial, blood was donated or used as a subject to be collected for a blood sample of more than 400 ml, or to donate blood or to undergo surgery during the test; 23. Participated in other clinical trials or studies of other drugs within 3 months prior to the injection of the drug; 24. Participants who were not fit to enter the group (such as those who were unable to understand and comply with the test requirements, were not fit to enter the group for safety reasons).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;PK; | — |
Countries
China
Contacts
Public ContactZhaohe Wang
Bio-thera Solutions, Ltd.
Outcome results
None listed