None listed
Conditions
Interventions
Experimental group 1:12.5 mg (1 medication+1 placebo)
Experimental group 2:25 mg (2 medication +2 placebo )
Experimental group 3:50 mg (8 medication +2 placebo)
Experimental group 4:100 mg (8 medication+2 placebo)
Experimental group 5:200 mg (8 medication+2 placebo)
Experimental group 6:400 mg (8 medication+2 placebo)
Experimental group 7:600 mg (4 medication+2 placebo)
Experimental group 8:800 mg (2 medication+2 placebo)
Sponsors
Affiliated Hospital of Guizhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Chinese healthy adult subjects, no gender limit, aged 18 to 50 years (including 18 and 50 years old); 2. Body weight >=50.0 kg for male subjects and >=45.0 kg for female subjects, with body mass index (BMI) between 19.0 and 25.0 kg/m^2 (including the boundary value); 3. Able to understand the informed consent, voluntarily participate in the experiment and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. With allergic constitution or a history of clinically significant food, drug allergies, or other allergic diseases (asthma, urticaria, eczema dermatitis, etc.) determined by researchers; Or known to be allergic to JAK inhibitors or to the excipients contained in the investigational drug; 2. Those with abnormal and clinically significant results of physical examination, vital signs, laboratory examination items and test related examinations and tests (such as chest X-ray examination, abdominal color ultrasound, blood pregnancy, alcohol breath examination, drug screening, ANA examination, tuberculin test, ECG examination, etc.) before enrollment; 3. Subjects with systolic blood pressure>140 mmHg and diastolic blood pressure>90 mmHg during the screening period; During the screening period, there were male subjects with QTcF>430 ms and female subjects with QTcF>450 ms in the electrocardiogram examination; 4. Screening for subjects who have undergone major surgical procedures within the first 3 months or plan to undergo surgery during the trial period; 5. Subjects with acute diseases within the first 2 weeks of screening; Clinically significant infection (such as upper respiratory tract infection, nasopharyngitis, urinary system infection, etc.) within 3 months before screening; Evidence of any infection within 7 days prior to screening; History of herpes simplex infection or recurrent (>1 occurrence) or disseminated herpes zoster; 6. Subjects with cardiovascular system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, malignant tumor, mental disease and other serious diseases; 7. History of dysphagia or any gastrointestinal system disease (or gastrointestinal resection, etc.) affecting absorption; 8. One of the AIDS virus antibody, treponema pallidum antibody, hepatitis B surface antigen and hepatitis C antibody tests is positive; 9. Subjects with a history of lipid metabolism defects, such as familial hyperlipidemia, lipoid nephropathy, or acute pancreatitis subjects with hyperlipidemia; 10. Positive drug screening (including morphine, methamphetamine, ketamine, dimethylenedioxyamphetamine, tetrahydrocannabinoid acid); 11. Those who have received the vaccine within 8 weeks before screening, or plan to receive the vaccine during the research process or within 8 weeks after the last study drug administration; 12. Subjects who have donated blood or lost >= 400 mL of blood or received blood transfusions within the first 3 months of screening; Or those who donate blood or have lost >= 200 mL of blood within one month prior to screening; 13. Those who have special dietary requirements or are unable to comply with the unified diet and corresponding regulations of the research center; 14. After inquiry, subjects who have smoked more than 3 cigarettes/day or an equivalent amount of tobacco within the first 3 months of screening; Or drink more than 14 units of alcohol every week (1 unit of alcohol ˜ 25 mL high Baijiu/100 mL wine/285 mL beer); Or those who do not agree to ban smoking or alcohol during the trial period; 15. Those who have taken any prescription drugs, over-the-counter drugs, any vitamin products, or Chinese herbal medicines (JAK inhibitors, immunosuppressants, etc.) within 14 days prior to screening; 16. Those who use strong inducers of liver metabolic enzymes (such as omeprazole, barbiturates, carbamazepine, amglutide, griseofulvin, trimethoprim, phenytoin, glumethide, rifampic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak time, Tmax;Peak concentration, Cmax;Apparent volume of distribution;Elimination rate constant;Terminal elimination half-life, t1/2;Clearance rate, CL;Area under the drug-time curve, AUC0-t;Area under the drug-time curve from 0h to infinite time, AUC0-8;Area under the drug-time curve for 0-72h, AUC0-72h;Clearance rate, CLr/f;Apparent volume of distribution, Vz/F; | — |
Countries
China
Contacts
Public ContactHe Yan /Fang Yi
Affiliated Hospital of Guizhou Medical University
Outcome results
None listed