rheumatoid arthritis
Conditions
Interventions
Group A:MY004567 tablet, multiple administration for 7 days (dosage 1)
Group B:placebo, multiple administration for 7 days
Sponsors
The Second Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Subjects shall have a full understanding of the test content and sign the informed consent before conducting to any research specific procedures. 2. No gender limit, subjects aged 18-45 years at the time of signing ICF (including 18 and 45 years). 3. >=50.0 kg for male, >=45.0 kg for female, body mass index (BMI) should be in the range of 19.0-26.0 kg/m2 at screening (including the critical value). 4. The blood hCG pregnancy test results of women must be negative at screening; Subjects and their partners agree to use a highly effective contraceptive method during the trial and for at least 90 days after drug administration (Informed information is provided in accordance with Appendix 1); Male subjects agree to no sperm donation during the trial and for at least 90 days after drug administration.
Exclusion criteria
Exclusion criteria: 1. History of food or drug allergies and those who were judged unsuitable for inclusion. 2. Lactating subjects; Women of childbearing age who have menstrual disorders within 90 days before drug administration; Women of childbearing age who have had unprotected intercourse with an opposite sex partner in the 28 days prior to drug administration. 3. Subjects who participate in other clinical trials within 3 months prior to screening or the date of drug administration in this trial was within the washout period of the previous test drug. 4. Non-physiological blood loss >=200 mL within 60 days before drug administration (including trauma, blood collection and blood donation) or plan to donate blood during the trial or within 30 days after drug administration. 5. Had a clinically significant medical condition in the 90 days prior to drug administration judged by investigators. 6. Had major surgery within 60 days prior to drug administration, or had any surgery within 28 days prior to drug administration. 7. Infectious diseases such as fever within 28 days prior to drug administration. 8. Use of any medication (including prescription and over-the-counter drugs) in the 14 days prior to drug administration. 9. Vaccination within 1 month prior to drug administration, or plan to receive the vaccine during the trial. 10. History of alcohol or drug abuse; or common drug tests do not meet the requirements at screening. 11. Smoking within 3 months prior to screening; Or urine cotinine screening results do not meet the requirements. 12. At screening, vital signs met any of the following criteria (as determined by the clinical research physician): systolic blood pressure in a sitting position 140 mmHg; diastolic blood pressure in a sitting position 90 mmHg; Pulse/heart rate 100 beats /min. 13. Positive in hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, human immunodeficiency virus (HIV) antibodies or syphilis antibodies; or positive in tuberculosis T-SPOT and have clinical significance judged by the investigators; or history of shingles. 14. A clinically significant gastrointestinal, liver or kidney abnormality at screening that is known or likely to affect drug intake, transport, absorption, distribution, metabolism or excretion. 15. Other factors that may affect the trial results and interfere with his/her participation in the trial judged by investigator, including but not limited to other medical history (such as history of mental disorders), vital signs, physical examination, electrocardiogram and/or clinical laboratory abnormalities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration;adverse event;vital signs;laboratory examination;routine 12-leads ECG;pregnancy check;physical examination;the levels of cytokines IL-6 and TNFa under R848 stimulation;C-reactive protein, tumor necrosis factor, IL-6, and IL-10 in serum samples; | — |
Countries
China
Contacts
Public ContactHu Wei
The Second Hospital of Anhui Medical University
Outcome results
None listed