A Double Blind, Placebo Controlled Ascending Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of the IKK Inhibitor, SAR113945, Following Intra-articular Administration in 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
- 40
- 试验地点
- 1
- 主要终点
- Standard safety investigations (Physical examinations, 12 lead ECGs, vital signs (Blood pressure, heart rate, body temperature) and laboratory tests (hematology/coagulation, biochemistry, quantitative urinalysis))
研究概览
简要总结
Primary Objective:
- Assess the safety and tolerability of single intra-articular doses of SAR113945 in patients with knee osteoarthritis.
Secondary Objective:
- Assess systemic exposure of SAR113945 following intra-articular delivery.
详细描述
The total study duration per subject ranges from 4 to 20 weeks broken down as follows:
- screening within 4 weeks before dosing,
- follow-up of 4 weeks (28 days) after the single dose of study medication,
- prolonged by a maximum of 12 weeks if plasma PK level > Limit Of Quantification (LOQ) at Day 28.
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
SAR113945
SAR113945, single dose according to dose escalation design
干预措施: SAR113945 (Drug)
Placebo
0.9% saline solution, single dose
干预措施: placebo (Drug)
结局指标
主要结局
Standard safety investigations (Physical examinations, 12 lead ECGs, vital signs (Blood pressure, heart rate, body temperature) and laboratory tests (hematology/coagulation, biochemistry, quantitative urinalysis))
时间窗: 4 weeks up to a maximum of 12 weeks
Examination of skin/soft tissue of injected knee
时间窗: 4 weeks up to a maximum of 12 weeks
Any reaction is classified as erythema, oedema, pain, papulae, haematoma and graded none, mild, moderate or severe.
Examination of knee joint of injected knee
时间窗: 4 weeks up to a maximum of 12 weeks
Any reaction is classified as effusion/worsening of effusion, warm and pain.
次要结局
- Pharmacokinetic parameters for SAR113945 and potential metabolites(s) from plasma concentration (i.e. AUC, Cmax, tmax, t1/2)(4 weeks up to a maximum of 16 weeks)
- Pharmacodynamic parameters (WOMAC Index, biomarkers relating to inflammation and cartilage/bone turnover)(4 weeks)