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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Criteria

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.