Rheumatoid Arthritis
Conditions
Interventions
10mg:HWH486
10mg:placebo
25mg:HWH486
25mg:placebo
50mg:HWH486
50mg:placebo
100mg:HWH486
100mg:placebo
200mg:HWH486
200mg:placebo
400mg:HWH486
400mg:placebo
600mg:HWH486
600mg:placebo
800mg:HWH486
800mg:placebo
Sponsors
West China Hospital of Sichuan University (WCSM/WCH)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy volunteers aged 18-45 years, half male and half female; 2. Body mass index was 18.0~28.0kg/m2 (including critical value); 3. he/she is in good health and has a normal medical history of heart, liver, kidney, digestive tract, respiratory system, nervous system and metabolic by the physical examination, vital signs examination, laboratory examination or electrocardiogram examination (clinically significant after judgment by the clinician); 4. Women who are negative in pregnancy tests or whose spouses plan to give birth within one month; and agree to take effective contraceptive measures within one month. 5. Sign the informed consent voluntarily; 6. Comply with the relevant hospital management regulations and test requirements after judgment by the clinician.
Exclusion criteria
Exclusion criteria: 1. women who are pregnant or breast-feeding; 2. have a significant history of clinical allergy, especially drug allergy, especially to the test drug and any ingredients in the adjuvant; 3. infectious diseases of heart, liver, kidney, digestive tract, respiratory system, nervous system and metabolic system; 4. patients with positive antibody test in virological examination (including hepatitis b, hepatitis c, HIV or TP) (clinically significant upon judgment by clinicians); 5. history of suspected or proven drug abuse; 6. smoking more than 5 cigarettes a day, those with alcohol intake exceeding 2 units per day (1 unit =360ml beer or 150 ml wine or 45ml liquor); 7. have donated or lost blood equal to or more than 400ml within three months before the test; 8. those who have participated in another drug test within three months before being selected; 9. have used any other drugs within two weeks before the start of the trial; 10. the researcher considers that the subject should not participate in the test, or the subject cannot participate in the test due to its own reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK;safety; | — |
Countries
China
Contacts
Public ContactZhongping Gou
West China Hospital, Sichuan University
Outcome results
None listed