A Randomized, Double-blind, Placebo-controlled Ascending Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SAR113945 (IKK Inhibitor) Following Intra-articular Administration in Japanese Patients With Knee Osteoarthritis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of patients with safety assessments (adverse events, vital signs, 12 lead ECGs and laboratory tests)
研究概览
简要总结
Primary Objective:
To assess the safety and tolerability of SAR113945 in Japanese patients with knee osteoarthritis after ascending single intra-articular doses
Secondary Objective:
To assess the pharmacokinetics of SAR113945 in Japanese patients with knee osteoarthritis after ascending single intra-articular doses
详细描述
Following the single dose of study medication, the study period for each patient will be 168 days.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（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
Dose 1
SAR113945 low dose
干预措施: SAR113945 (Drug)
Dose 2
SAR113945 medium dose
干预措施: SAR113945 (Drug)
Dose 3
SAR113945 high dose
干预措施: SAR113945 (Drug)
Placebo
Placebo
干预措施: placebo (Drug)
结局指标
主要结局
Number of patients with safety assessments (adverse events, vital signs, 12 lead ECGs and laboratory tests)
时间窗: up to 24 weeks
Examination of skin/soft tissue of injected knee, and knee joint
时间窗: up to 24 weeks
Examination of skin/soft tissue of injected knee: Any reaction is classified as erythema, edema, pain, hematoma and graded none, mild, moderate or severe. Examination of knee joint of injected knee: Any reaction is classified as effusion/worsening of effusion, warmth and pain.
次要结局
- Pharmacokinetic parameter (AUC)(21 time points up to 24 weeks)
- Pharmacokinetic parameter (Cmax)(21 time points up to 24 weeks)
- Pharmacokinetic parameter (tmax)(21 time points up to 24 weeks)
- Pharmacokinetic parameter (t1/2)(21 time points up to 24 weeks)
- Pharmacodynamic parameter (WOMAC index)(up to 24 weeks)
- Pharmacodynamic parameter (biomarkers relating to osteoarthritis)(up to 24 weeks)