A Phase I Study Evaluating the Safety of Intra-Articular Sc-rAAV2.5IL-1Ra in Subjects With Moderate Osteoarthritis of the Knee
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Number of subjects experiencing severe adverse events.
研究概览
简要总结
This study seeks to determine the safety of three different doses of sc-rAAV2.5IL-1Ra delivered by intra-articular injection into one knee joint of patients with moderate OA of the knee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 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
Low Dose Group
Subjects will receive a single intra-articular 2mL injection consisting of 10{11} viral genomes.
干预措施: sc-rAAV2.5IL-1Ra (Drug)
Medium Dose Group
Subjects will receive a single intra-articular 2mL injection consisting of 10{12} viral genomes.
干预措施: sc-rAAV2.5IL-1Ra (Drug)
High Dose Group
Subjects will receive a single intra-articular 2mL injection consisting of 10{13} viral genomes.
干预措施: sc-rAAV2.5IL-1Ra (Drug)
结局指标
主要结局
Number of subjects experiencing severe adverse events.
时间窗: 53 weeks
Assess the local and systemic safety of three different doses of sc-rAAV2.5IL-1Ra delivered by intra-articular injection into one knee joint of patients with moderate OA of the knee.
次要结局
未报告次要终点