Rheumatoid arthritis
Conditions
Interventions
Experimental group:Oral HWH486 capsules
Control group:HWH486 capsule simulator
Sponsors
National Drug Clinical Trial Institute, West China Hospital of Sichuan University
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 45 years, half male and half female; 2.Calculated by body mass index = weight (kg)/ height^2(m^2), within the range of 18~28 (including the boundary value); 3.After medical history, physical examination, vital signs, blood routine, urine routine, stool routine+occult blood, blood biochemistry (liver function, kidney function, electrolyte, pancreatic amylase, lipase, blood lipid, fasting blood glucose), blood coagulation function, thyroid function and anti-thyroid antibodies (FT3, FT4, TSH, TPOAb, TGAb, TRAb), pathogenic microbiology examination (Hepatitis B virus markers (hepatitis B two-and-a-half), hepatitis C antibody, HIV antibody, treponema treponema antibody), 12-lead electrocardiogram, thyroid color doppler ultrasound, upper abdominal CT, chest X-ray, etc., the researchers determined that the volunteers were healthy; 4.Female subjects with negative blood pregnancy test; There is no pregnancy plan during the whole clinical trial and within 3 months after the last administration, and it is agreed to adopt medically accepted and reliable contraceptive methods during the trial and within 3 months after the last administration. Reliable contraceptive methods accepted by medicine refer to tubal ligation, hysterectomy, abstinence and the simultaneous use of condoms and/or vaginal diaphragms when using intrauterine devices, etc.; 5.Voluntary participation and signing of informed consent; 6.According to the judgment of the researcher, the subject is willing and able to comply with all the study requirements.
Exclusion criteria
Exclusion criteria: 1.Pregnant and lactating women, subjects with pregnancy plans during clinical trials and within 3 months after the last administration; 2.Allergic constitution; Have a clear history of drug allergy, especially those with a similar structure to the drug in the study; Allergic diseases; 3.Patients with history of present illness of circulatory system, respiratory system, digestive system, urinary system, blood system, endocrine system, neuropsychiatric system, metabolic, rheumatic, hereditary and infectious diseases,etc. 4.Hepatitis B surface antigen, hepatitis C antibody, HIV antibody positive, Treponema pallidum antibody positive; 5.Heart rate is lower than 60 beats/min; 6.Drug abusers; 7.Smokers (smoking more than 5 cigarettes per day or using a considerable amount of nicotine products), alcoholics [alcohol intake exceeds 2 units per day on average (1 unit =12 ounces or 360mL beer, 5 ounces or 150mL liquor, 1.5 oz or 45mL distilled liquor)]; 8.Patients have participated in blood donation or collected more than 400ml of blood in the 3 months before the trial administration; 9.Patients have participated in any clinical trials within 3 months before the trial administration; 10.Patients have used any drugs (including traditional Chinese medicine) within 2 weeks before the trial administration; Vaccinated within one month before the trial administration; Received biological agents (antibodies or their derivatives) within 3 months before the test administration; 11.Researchers think that it is not suitable for inclusion (such as infirmity, poor compliance, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic evaluation;Evaluation of safety and tolerance;Pharmacokinetics/pharmacodynamics evaluation;Pharmacodynamic evaluation; | — |
Countries
China
Contacts
Public ContactFeng Ping
West China Hospital, Sichuan University
Outcome results
None listed