Multiple Doses Escalation Study of SHR0302 in Rheumatoid Arthritis (RA) Patients

A Phase I, Randomized, Placebo-Controlled, Multiple Doses Escalation Study to Investigate Safety, Pharmacokinetics and Pharmacodynamics of SHR0302 in Patients With RA

Condition: Rheumatoid Arthritis Intervention: Drug: SHR0302; Drug: SHR0302 placebo comparator Phase: Phase 1 Study Type: Interventional Study Design: Treatment, Parallel Assignment, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Randomized

Inclusion Criteria:

• Male or female subjects who are 18~70 years of age on the day of signing informed consent,
• Have a diagnosis of RA meeting the 1987 ACR/EULAR criteria of RA and ACR functional class I-III,
• Body mass index (BMI = weight/height squared (kg/m2)) within the range of 19 to 30,
• Have agreed to not use any anti- rheumatic drug except for study drugs during the study period.

Exclusion Criteria:

• Current therapy with any disease modifying anti-rheumatic drug (DMARD), with the exception of Methotrexate (MTX), Leflunomide, sulfasalazine, antimalarials, gold preparations, penicillamine, which must have discontinued for a period of at least 7 t1/2s prior to dosing,
• Previous RA treatment with DMARDs or drugs with strong immunosuppressive effect in 3 months prior to dosing (12 months for rituximab or other B cell depleting agents),
• Previous therapy with NSAIDs or oral glucocorticoids in 2 weeks before dosing,
• Any parenteral (intramuscular or intravenous injection) or intra-articular corticosteroids therapy in 4 weeks before dosing,
• Previous treatment with interferons in 4 weeks before dosing.