Comparison of the Safety and Pharmacokinetics of Two SAR153191 (REGN88) Drug Products in Rheumatoid Arthritis Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Occurrence of potentially clinically significant abnormalities in clinical laboratory test results
研究概览
简要总结
Primary Objective:
Assess the comparative safety and tolerability of two SAR153191 (REGN88) drug products after a single dose administration in rheumatoid arthritis patients.
Secondary Objective:
Assess the comparative pharmacokinetic profiles of the two SAR153191 (REGN88) drug products after a single dose administration in rheumatoid arthritis patients.
详细描述
The duration of the study period per subject is 5-7 weeks broken down as follows:
- Screening: 1 to 14 days,
- Treatment: 1 day (2 overnight stays at the study site),
- Follow-up: up to 5 weeks after dosing (an additional outpatient follow-up may be scheduled depending on the last results).
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SAR153191 drug product 1
SAR153191 drug product 1 in a single injection.
Methotrexate (stable dose) and folic/folinic acid are continued as background therapy.
干预措施: SAR153191 (REGN88) (Drug)
SAR153191 drug product 2
SAR153191 drug product 2 in a single injection.
Methotrexate (stable dose) and folic/folinic acid are continued as background therapy.
干预措施: SAR153191 (REGN88) (Drug)
结局指标
主要结局
Occurrence of potentially clinically significant abnormalities in clinical laboratory test results
时间窗: 5 weeks
Occurrence of Adverse Events
时间窗: 5 weeks
次要结局
- Pain evaluation using the Present Pain Intensity (PPI) verbal questionnaire(2 days)
- Pain evaluation using Visual Analog Scale (VAS)(2 days)
- Diameter of the erythema at injection site(2 days)
- Diameter of the edema at injection site(2 days)
- Serum concentration of SAR153191: Maximum plasma concentration (Cmax), first time to reach Cmax (tmax), area under the plasma concentration (AUClast and AUC)(5 weeks)