Rheumatoid arthritis, ankylosing spondylitis
Conditions
Interventions
0.5mg:Three received 0.5mg of the test drug and one received placebo
1.5mg:Three received 1.5mg of the test drug and one received placebo
5mg:Six received 5mg of the test drug and two received placebo
12.5mg:Six received 12.5mg of the test drug and two received placebo
25mg:Six received 25mg of the test drug and two received placebo
50mg:Six received 50mg of the test drug and two received placebo
75mg:Six received 75mg of the test drug and two received placebo
100mg:Six received 100mg of the test drug and two received placebo
Sponsors
Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Have fully understood the study, voluntarily signed the written informed consent, and can comply with the requirements and restrictions listed in the informed consent; 2. Chinese male or female subjects aged 18-65 (including 18 and 65); 3. At the time of screening, male weight >=50 kg, female weight =45 kg, and body mass index (BMI) between 19.0 and 26.0 kg/m2 (including 19.0 kg/m2 and 26.0 kg/m2; BMI = weight ÷ height 2); 4. During screening, the results of all examinations (including physical examination, vital signs examination, blood routine, urine routine, blood biochemistry, coagulation function, serum virology, 12-lead electrocardiogram, chest radiograph, etc.) showed no abnormality or slight abnormality, but no clinical significance according to the researchers; 5. The subject or his or her partner does not plan to become pregnant during the study period or within 6 months after the final administration of the study drug, voluntarily uses effective contraception (contraceptive pill is not allowed during the study period) to avoid becoming pregnant, and the subject does not donate sperm or eggs (oocytes, oocytes) for reproductive or assisted reproductive purposes.
Exclusion criteria
Exclusion criteria: 1) Pregnant women, lactating women, or women of childbearing age have positive pregnancy screening results; 2) The investigator determines that there is any disease (such as acute gastritis, gastrointestinal ulcer, purpura, lupus erythematosus, etc.) or medical history (such as history of intracranial hemorrhage, history of intraocular hemorrhage, history of hemophilia, history of willebrand disease, etc.) that can alter or increase bleeding tendency; 3) A history of clinically significant acute drug or food allergic reactions, or allergic conditions (such as allergy to two or more drugs, food or pollen), or a history of allergic STDS (such as asthma, urticaria, eczema dermatitis, etc.) within 2 weeks before screening, Or it is possible or clear to be allergic, hypersensitive or clinically significant to the study drug (including similar drugs or control drugs) and any excipients, as determined by the investigator; 4) Any result of hepatitis B surface antigen, hepatitis C antibody, HIV antigen antibody combined test and treponema pallidum antibody test is positive; 5) Any of the following foods, drugs, or treatments were used prior to initial administration: ? first dosing or within 2 weeks before five (meter) with long half-life used immunosuppressant drugs, such as JAK inhibitor, TNF alpha inhibitors, etc.; ? first dosing or within 2 weeks before five (meter) with long half-life used P - gp, CYP3A4 and CYP2C8 inhibitors or inducers; ? first dosing within 2 weeks before using any prescription drugs, herbs, non-prescription drugs and food supplements, including vitamins, health food, etc.); ? first delivery within 1 week before taking food or drinks containing grapefruit (grapefruit); ? within 72 hours before delivery for the first time using alcohol, caffeine, or xanthine food or drink. 6) Drug or substance abuse, alcoholism or smoking: ? has a history of drug or drug abuse, drug abuse, or screening a positive screening; ? screening average weekly drinking more than 3 months before 14 units (1 unit of material 17.7 mL of ethanol, which is 1 unit material 360 mL 5% alcohol content of beer, or alcohol 45 mL, 40% of the amount of liquor or alcohol 12% of the amount of wine, 150 mL), or screening positive for alcohol breath test results, Or unable to completely stop consuming any food or drink containing alcohol during the study period; ? screening before 3 months average daily smoking more than 5 pieces, or can't use any tobacco products during the study period has come to a full stop; ? screening before 3 months, an average of more than 500 mg of caffeine per day (5 cups of tea or coffee, or eight cans of soda or other caffeinated products). 7) Blood donation (including component donation) or blood loss of =400 mL within 3 months prior to screening, blood donation (including component donation) or blood loss of >=200 mL within 1 month prior to screening or blood transfusion received, or planned to donate blood or blood components within 1 month after the study period; 8) Difficulty in blood collection or inability to tolerate multiple venipunctures, or history of needle fainting or blood fainting judged by the researcher as clinically significant; 9) have received inactivated vaccine, live vaccine, live attenuated vaccine or vaccine with any live virus component within 3 months prior to screening, or plan to receive such vaccine during the study period or within 3 months after the study is completed; 10) Have experienced major trauma or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety index;okinetics; | — |
Countries
China
Contacts
Public ContactPing Feng
West China Hospital of Sichuan University
Outcome results
None listed