rheumatoid arthritis
Conditions
Interventions
2 Groups:QL0902 and Enli
Sponsors
Phase I Clinical Laboratory, Clinical Pharmacology Center, Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male subjects between the ages of 18 and 40 (including the boundary value); 2. Male subjects have a body weight = 50.0 kg and a body mass index (BMI) between 19 and 26 kg/m 2; 3. Voluntary signing of written informed consent.
Exclusion criteria
Exclusion criteria: 1. (consultation) patients who have had or are currently suffering from any serious clinical diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities or any other diseases that may interfere with the test results; 2. special to the well known allergy to any ingredient or protein to the human body allergic constitution and susceptibility to immunoglobulin to other drugs have significant allergies; 3. (consultation) known factors of severe bleeding that can affect venous blood collection; 4. (consultation) patients with a history of malignant tumor; 5. patients who had had shingles more than twice or shingles in the previous year; 6. (consultation) those who have received surgery within 4 weeks before the trial, or plan to have surgery during the study period; 7. (consultation) those who have taken any medicine (including vitamins and Chinese herbal medicine) within 14 days before the test; 8. (follow-up) any drugs that inhibit or induce liver metabolism of drugs (e.g., inducers -- barbiturates, carbamazepine, phenytoin, glucocorticoid, omeprazole) were used within 30 days before the test;Inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines); 9. any anti-tnf - biologic agent has been used; 10. (consultation) use any biological agent within 3 months before enrollment; 11. (consultation) have received active or attenuated vaccine within 3 months prior to administration or during the planned trial period, and have received immunosuppressive agents within 3 months prior to administration; 12. (consultation) those who have taken or participated in any clinical trial of any drug within 3 months prior to the trial; Blood donors within 3 months before the test; 14. (consultation) those who cannot use one or more non-drug contraceptive measures during the trial; 15. (consultation) those who have special requirements on diet and cannot observe the unified diet; 16. (consultation) drinking excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup =250 mL) every day; 17. (consultation) smokers or those who smoked more than 5 cigarettes per day 3 months before the test; 18. (consultation) heavy drinkers or regular drinkers within 6 months prior to the study, i.e., drinking more than 14 units of alcohol per week (1 unit =360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine); 19. (consultation) drug abusers or those who have used soft drugs (e.g., marijuana) 3 months before the test or hard drugs (e.g., cocaine, benzodiazepine, etc.) 1 year before the test; 20. there is active infection, including acute and chronic infection and local infection; 21. patients with a history of tuberculosis or latent tuberculosis infection or with clinical manifestations suspected of tuberculosis (including but not limited to tuberculosis), positive for tuberculosis screening (t-spot), or active tuberculosis shown on chest X-ray; 22. patients with abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg);Heart rate 100 BPM) or physical examination, electrocardiogram, imaging, laboratory examination and other abnormalities have clinical significance (subject to the judgment of the clinician); 23. subjects may be unable to complete t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma drug concertration; | — |
Countries
China
Contacts
Public ContactGuo-ping Yang
The Third Xiangya Hospital of Central South University
Outcome results
None listed