A Phase I, Randomized, Placebo-Controlled, Multiple Doses Escalation Study to Investigate Safety, Pharmacokinetics and Pharmacodynamics of SHR0302 in Patients With RA
试验速览
- 阶段
- 1 期
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Adverse events and the number of volunteers with adverse events as a measure of safety and tolerability.
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
SHR0302
Multiple ascending doses (2, 5, 10, 25 mg), oral tablets
干预措施: SHR0302 (Drug)
SHR0302 placebo comparator
Multiple ascending doses (2, 5, 10, 25 mg), oral tablets (matching corresponding study medication)
干预措施: SHR0302 placebo comparator (Drug)
结局指标
主要结局
Adverse events and the number of volunteers with adverse events as a measure of safety and tolerability.
时间窗: up to 48 hrs postdose
Tests will be performed to assess whether the study drug has any potentially adverse effect (laboratory tests on blood and urine for functioning of organs; cardiovascular testing, i.e. of heart and blood circulation). Also, participants will carefully be monitored by medical staff for vital signs, and asked to report any side effect experienced in the course of the study
次要结局
- The maximum plasma concentration (Cmax) of SHR0302(At protocol-specified times up to 48 hrs postdose)
- The area under the plasma concentration-time curve (AUC) of SHR0302(At protocol-specified times up to 48 hrs postdose)
- t1/2 of SHR0302(At protocol-specified times up to 48 hrs postdose)