Rheumatoid arthritis
Conditions
Interventions
1mg:TQH3910 tablets / placebo
4mg:TQH3910 tablets / placebo
8mg:TQH3910 tablets / placebo
16mg: TQH3910 tablets / placebo
32mg:TQH3910 tablets / placebo
48mg:TQH3910 tablets / placebo
Sponsors
The Second Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Male and Female Subjects aged between 18 to 55 including 18 years and 55 years old; 2. Weight no less than 50 kilos for males and 45 kilos for females. BMI(weight/height) between 18.0kg/m^2 to 24.0kg/m^2; 3. Sign ICF and understand the trial procedure, and agree to complete the trial according to protocol requirements; 4. Subjects and partners agree to use effective anti-conception measures(non-contraceptive pills) from screening to 6 months after the last treatment of the study drug;
Exclusion criteria
Exclusion criteria: 1. Female volunteers who are pregnant or lactating; 2. Subjects with previous or current diseases/abnormalities of the circulatory system, endocrine system, metabolic system, urinary system, digestive system, skin, blood system, nervous system or mental system, or other chronic or acute diseases, who are evaluated by the researcher as not suitable to participate in the study; 3. During the screening period, the results of vital signs, physical examination, laboratory examination, 12 lead ECG, abdominal color ultrasound, and chest X-ray film are abnormal and clinically significant; 4. Subjects who are positive for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV), human immunodeficiency virus antibody (anti-HIV), and Treponema pallidum antibody (anti-TP); 5. Clinically significant infection history, including upper respiratory tract infection (URTI) and lower respiratory tract infection (LRTI), occurred 14 days before and during the screening, and antibiotics or antiviral drugs were needed; 6. Those who had undergone surgery within 4 weeks before screening or planned to undergo surgery during the study period; 7. The subjects who participated in other clinical trials within 3 months before screening; 8. The subjects who received immunoglobulin or blood products treatment within 30 days before screening; 9. Those who lost blood or donated more than 400 ml of blood within 2 months before screening; 10. The subjects who have potential blood collection difficulties, with a history of needle fainting and blood fainting; 11. The subjects who have any definite history of drug or food allergy, especially those who are allergic to ingredients similar to the test drug; 12. Within 6 months before screening, those who smoke more than 5 cigarettes/day or use a considerable amount of nicotine or nicotine-containing products, or cannot stop using any tobacco products during the test; 13. The subjects who have long-term alcoholism or drink more than 14 units of alcohol per week within 3 months before screening (1 unit =360 ml beer or 45 ml spirits with 40% alcohol or 150 ml wine), or cannot abstain during the test, or have a positive alcohol breath test; 14. Have a history of drug abuse or positive urine drug screening; 15. The subjects who received any marketed or researched biological agent treatment within 4 months or 5 half-lives (whichever is longer) before the screening; 16. The subjects who took any prescription drugs, over-the-counter drugs, herbs, and health products within 4 weeks before the screening, except vitamin products; 17. The subjects who used any systemic cytotoxicity or systemic immunosuppressant within 6 months before screening or during the study, or use any local cytotoxin or local immunosuppressive drug within 30 days before screening or within 5 half-lives (whichever is longer) or during the study; 18. Any situation that the researcher believes will bring safety risks to the subjects in the test or may interfere with the conduct of this study, or the researcher believes that the subjects may not be able to complete this study or may not be able to comply with the requirements of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Laboratory examination;Adverse events;Hematology;Blood Chemistry;Urinalysis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics; | — |
Countries
China
Contacts
Public ContactBikui Zhang
The Second Xiangya Hospital of Central South University
Outcome results
None listed