Rheumatoid Arthritis
Conditions
Interventions
Group 1:H018 tablets 10mg (half tablets), single dose
Group 2:H018 tablets 20mg (1 tablet) or placebo 20mg (1 tablet), single dose
Group 3:H018 tablets 40mg (2 tablets) or placebo 40mg (2 tablets), single dose
Group 4:H018 tablets 80mg (4 tablets) or placebo 80mg (4 tablets), single dose
Group 5:H018 tablets 120mg (6 tablets) or placebo 120mg (6 tablets), single dose
Group 6:H018 tablets 160mg (8 tablets) or placebo 160mg (8 tablets), single dose
Sponsors
The Second Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Healthy adult male subjects aged 18~55 (inclusive) (health refers to normal or abnormal results of medical history inquiry, physical and vital signs examination, laboratory examination, 12 lead ECG and other examinations, but no clinical significance judged by the researcher); 2. Body weight = 50.0kg and body mass index (BMI): 19.0~26.0kg/m2 (including 19.0 kg/m2 and 26.0 kg/m2, body mass index=weight/height 2, 1 decimal place reserved); 3. Subjects voluntarily signed the informed consent form; 4. The subjects promised that they would not have a birth plan or sperm donation plan during the period from the administration to 6 months after drug withdrawal, and would take appropriate contraceptive measures to avoid pregnancy of their partners; 5. Subjects have a good life and can maintain good communication with researchers and comply with various requirements of clinical trials.
Exclusion criteria
Exclusion criteria: 1. Persons with nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, bone and other system diseases, infectious diseases, and major organ diseases; 2. History of food and drug allergy or atopic allergic disease with clinical significance (such as asthma, urticaria, eczema dermatitis, etc.) or known allergy to test drug ingredients and excipients or JAK inhibitors (such as Tofatib, Baretinib, Figotinib, etc.); 3. Family history of long QT syndrome (grandparents, parents and siblings); 4. Those who have undergone surgery within 3 months before screening, or who plan to undergo surgery during the study period, and any disease or medical history that may significantly affect drug absorption, distribution, metabolism and excretion, or any disease that the investigator believes may pose a hazard to the subject, such as: 1). Inflammatory bowel disease, gastric ulcer, duodenal ulcer, gastrointestinal/rectal bleeding, persistent nausea or other gastrointestinal abnormalities with clinical significance; 2). Have a large history of gastrointestinal surgery in the past (such as: gastrectomy, gastrointestinal anastomosis, intestinal resection, gastric bypass, stomach segmentation or gastric sac banding, cholecystectomy, except for appendicitis surgery and anus removal); 3). There is evidence of liver disease or clinically significant liver function impairment during screening (such as AST, ALT or total bilirubin>1.5 times ULN); 4). There was a history or evidence of kidney disease or renal insufficiency at the time of screening, showing clinically significant creatinine abnormalities or abnormal urine composition (such as proteinuria); 5). Urinary obstruction or difficulty in emptying urine during screening period; 5. Those who are positive for hepatitis B virus surface antigen, hepatitis C virus IgG antibody, syphilis spirochete specific antibody, human immunodeficiency virus antibody and antigen (P24); 6. Those who have used any prescription drugs, non prescription drugs, Chinese herbal medicine or health care products within 14 days before the first administration; 7. Those who drink too much tea, coffee or caffeinated drinks (more than 8 cups per day on average, 1 cup=250 mL) within 3 months before screening; Or taking tea or any food or drink containing caffeine (such as coffee, chocolate, etc.) within 48 hours before administration; 8. Drinks or foods rich in grapefruit (i.e. grapefruit) (such as grapefruit, grapefruit juice, grapefruit jam, etc.) within 14 days before screening; Or ingested any drink or food rich in grapefruit (i.e. grapefruit) within 48 hours before administration; 9. Those who smoke more than 5 cigarettes a day on average within 3 months before the test or cannot be prohibited from smoking during the whole hospitalization period; 10. Those who frequently drank alcohol within 3 months before the test, i.e., more than 2 units of alcohol (1 unit=360mL beer or 45mL liquor or 150mL wine with 40% alcohol) on average every day, or those who could not abstain from alcohol during the test; Or alcohol breath test is positive; 11. Blood donation or blood loss = 400mL within 3 months before the test or blood donation within 3 months after drug withdrawal during the planned medication period; 12. Those who had taken drugs within 3 months before the test or had a history of drug abuse/dependence within 12 months or had posi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration-time curve from zero time to inferred infinite time AUC0-8;The area under the plasma concentration-time curve from zero time to the last measured concentration (Clast) time AUC0-t;Maximum plasma concentration Cmax;Time to peak plasma concentration Tmax;Elimination rate constant Kel;Average dwell time MRT;Elimination half-life t1/2;Clearance rate CL/F;Apparent volume of distribution Vd/F;Extrapolated area percentage [%] AUC_%Extrap;Adverse event Ae;Renal clearance CLR;Vital signs and physical examination;Laboratory examination;ECG examination;Inhibition rate; | — |
Countries
China
Contacts
Public ContactQuanying Zhang
Outcome results
None listed