A Study on the Safety and Tolerability of RGL-193 Injection in Patients With Advanced Parkinson's Disease - An Open-label and Dose-escalation Clinical Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- the number of patients with clinically significant change from baseline in laboratory examination
研究概览
简要总结
A safety study in patients with Parkinson's disease.
详细描述
This is an open-label, dose-escalation safety and tolerability study in patients with advanced Parkinson's disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 70 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
RGL-193（low-dose）Treatment group
Each side of the putamen received 150 μL of RGL-193, with a unilateral dose of 1.5×10^11 VG and a bilateral dose of 3.0×10^11 VG.
干预措施: RGL-193（low-dose） (Drug)
RGL-193（high-dose）Treatment group
Each side of the putamen received 200 μL of RGL-193, with a unilateral dose of 5.0×10^11 VG and a bilateral dose of 1.0×10^12 VG.
干预措施: RGL-193（high-dose） (Drug)
结局指标
主要结局
the number of patients with clinically significant change from baseline in laboratory examination
时间窗: 26 weeks after administration
the number of patients with clinically significant change in physical examination
时间窗: 26 weeks after administration
the number of patients with adverse events
时间窗: 26 weeks after administration
the number of patients with clinically significant change from baseline in vital signs value
时间窗: 26 weeks after administration
the number of patients with clinically significant change from baseline in 12-ECG values
时间窗: 26 weeks after administration
the number of patients with clinically significant change in brain MRI
时间窗: 26 weeks after administration
次要结局
未报告次要终点
研究者
Chun-Feng Liu
Chief Physician
Second Affiliated Hospital of Soochow University