Rheumatoid arthritis
Conditions
Interventions
experimental group:KL130008 capsule
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Be able to understand the procedures and methods of this study, be willing to strictly abide by the clinical trial protocol to complete this trial, and voluntarily sign the informed consent; 2. The age when signing the informed consent form is 18 to 65 years old (including the boundary value), and the gender is not limited; 3. Body mass index within the range of 18.0~26.0 kg/m^2 (including the boundary value); 4. Diagnosed with rheumatoid arthritis, in line with the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria, and the ACR functional classification was grades I to III during screening; 5. During the study period and within 3 months after the end of the administration, the subjects with fertility (regardless of men and women) must take effective contraceptive measures.
Exclusion criteria
Exclusion criteria: 1. Known history of allergic reaction to any component of the study treatment and/or other similar products; 2. Previous use of any of the following drugs or treatments: (1) Have used JAK inhibitor drugs (including but not limited to tofacitinib, baricitinib, Peficitinib, Upadacitinib and Filgotinib) within 3 months before the first administration of the test drug or participated in clinical trials of these drugs and used test drug; (2) Use leflunomide, sulfasalazine, chloroquine/hydroxychloroquine, gold preparation, penicillamine, and stop medication time = 12 days can be enrolled], 4 days of sulfasalazine, 10 months of chloroquine/hydroxychloroquine, 26 weeks of gold preparation, 34 days of penicillamine); (3) The use of biologics disease-modifying antirheumatic drugs (bDMARDs) within 3 months before the first administration of the test drug, including but not limited to anti-tumor necrosis factor (TNF)-a antagonists, interleukin (IL)-1 Antagonists, IL-6 antagonists, anti-CD20 monoclonal antibodies and T cell costimulatory molecule inhibitors, etc.; (4) Have used drugs with strong immunosuppressive or immunomodulatory effects within 3 months before the first administration of the test drug, such as paphrin, mycophenolate mofetil, cyclosporine, tacrolimus, azathioprine , 6-mercaptopurine, etc.; (5) Have used any non-steroidal anti-inflammatory drugs (NSAIDs) or oral glucocorticoids within 2 weeks before the first administration of the test drug; (6) Have used intramuscular or intravenous or intra-articular injection of corticosteroids, or oral administration of Chinese patent medicine or Chinese herbal medicine such as Tripterygium wilfordii within 1 month before the first administration of the test drug; (7) Received interferon therapy within 4 weeks before the first administration of the test drug, such as Rointerferon, Ganneng, Rebetron, Alferon-N, PegIntron, Avonex, Betalon, Ganfujin, Interferon ?- 1b, Peloxin, Andafen, Dean, Fukangtai, etc.; (8) Vaccination or exposure to live vaccine or live attenuated vaccine within 3 months before the first administration of the test drug or planning to receive live vaccine or live attenuated vaccine during the test; (9) Participated in any clinical trials of drugs or medical devices within 3 months before the first administration of the test drug and used the test drug (including the placebo control group) or treatment; (10) Have used CYP3A strong inhibitor or strong inducer drugs (including prescription drugs, over-the-counter drugs, vitamins and food supplements) within 4 weeks before the first administration of the test drug; (11) Are using other drugs (including prescription drugs, non-prescription drugs) other than the above drugs and the drug withdrawal time before randomization is less than 7 drug half-lives; 3. History or evidence of any of the following diseases: (1) Patients with other systemic inflammatory diseases other than RA (except secondary Sj?gren's syndrome), including but not limited to juvenile chronic arthritis, Crohn's disease, ulcerative colitis, psoriasis Arthritis, systemic lupus erythematosus, ankylosing spondylitis, reactive joint disease, systemic vasculitis, or gout; (2) Felty syndrome (Felty syndrome, or arthritis-neutropenia-splenomegaly syndrome); (3) Active infection at the time of screening or viral
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| hematology panel;Blood chemistry panel;Pharmacokinetic profile: plasma KL130008 concentration; | — |
Countries
China
Contacts
Public ContactLiu Yi, Feng Ping
Clinical Trial Center, West China Hospital, Sichuan University
Outcome results
None listed