Rheumatoid arthritis
Conditions
Interventions
Treatment group:KL130008 capsules
Placebo group:Placebo
Sponsors
West China Hospital Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18-60 years old healthy males or females; 2. Male 50 kg weight80 kg, female 45 kgweight80 kg, body mass index (BMI) of 19 to 25 kilograms per meter squared (kg/m2) inclusive; 3. Completed informed consent form must be provided; Participants are able to communicate well with the investigator and be able to complete the study in accordance with the research regulations.
Exclusion criteria
Exclusion criteria: The subject must be excluded from participating in the trial if the subject: 1) Comprehensive physical examination (vital signs, physical examination), routine laboratory tests (blood routine, blood biochemistry, urine routines, etc.), Chest X-ray, abdominal ultrasound exam, etc., abnormally is determined by the investigator; 2) Severe or uncontrolled systemic disease as evidenced, in the opinion of the investigator (Severe liver damage, interstitial lung disease); Current unstable/decompensated cardiopulmonary function; Uncontrolled hypertension; irritable bowel syndrome; Crohn's disease; Ulcerative colitis, etc.,a disease that causes chronic gastrointestinal disorders; 3) History of malignancy; 4) Have a history of rheumatic disease; 5) Any infection that has been clinically determined within 3 months prior to enrollment by the investigator occurred; 6) Participants have been exposed to TB epidemic area within 2 months prior to enrollment. Those with a history of tuberculosis or active tuberculosis, or those with positive T-SPOT.TB test results; Note: TB-epidemic areas refer to India, Indonesia, the Philippines and Pakistan. 7) Have had symptomatic herpes zoster or herpes simplex infection within 90 days prior to the first dose; 8) Have a known hypersensitivity to drugs or any component of this investigational product, or being allergic; 9) Acute disease patient who has been clinically determined by the investigator within 1 month prior to enrollment; 10) Immunization received a live vaccine or attenuated vaccine on one month prior to enrollment; 11) ECG screening QTcF > 450 ms, ( Fridericias formulaQTcF = QT/(RR)1/3), Other clinically determined by the investigator in the electrocardiogram; 12) Within 2 weeks prior to enrollment, the function of hematopoiesis, liver and kidney can't reach the following standards by the laboratory tested; (1) Hematopoietic function: Neutrophil absolute count > lower normal limit (LLN), White blood cell count> LLN & LLN, Platelet count> LLN & LLN, Reticulocyte> LLN, Hematocrit(HCT)> 30%; (2) Liver function: Total bilirubin LLN & LLN; 13) The results of C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) were higher than the upper limit of normal value, and determined by the investigator that the abnormality was clinically significant; 14) Show evidence of positive hepatitis B surface antigen, positive hepatitis C antibody, positive HIV antibody, or positive syphilis antibody Cannot follow a uniform diet or dysphagia; 15) Can not follow a uniform diet or dysphagia; 16) Take any clinical trial drug within 3 months prior to enrollment; 17) Patients who have received a JAK inhibitor (such as Tofacitinib) or any other similar structural drug prior to enrollment; 18) Those who have used other drugs within 14 days prior to enrollment, including prescription drugs, over
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| hematology panel;Blood chemistry panel;pharmacokinetic and pharmacodynamic parameters; | — |
Countries
China
Contacts
Public ContactPing Feng
West China Hospital, Sichuan University
Outcome results
None listed