NCT02970019已完成1 期
A Double-blind, Placebo-controlled Study to Determine Safety, Tolerability, Pharmacokinetic of K0706.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- Adverse events
研究概览
简要总结
This is a safety, tolerability and pharmacokinetic study in subjects with Parkinson's disease
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to give written, and dated, informed consent (or legally acceptable representative/impartial witness when applicable) and is available for the entire study
- •Willing and able to comply with the scheduled visits, treatment plan, laboratory testing, study procedures, and restrictions (in the Investigator's opinion), and be accessible for follow-up
- •Male or female aged 18 to 65 years (both inclusive)
- •Diagnosed with Parkinson's disease
排除标准
- •Clinical diagnosis of genetic form of Parkinson's disease, or drug-induced parkinsonism
- •Diagnosis of Parkinson's disease Dementia (probable, possible)
- •Presence of severe dyskinesias
- •History of brain surgery for Parkinson's disease
研究组 & 干预措施
K0706
Experimental
K0706 will be administered once a day
干预措施: K0706 (Drug)
Placebo
Experimental
Placebo will be administered once a day
干预措施: Placebo (Drug)
结局指标
主要结局
Adverse events
时间窗: 4 weeks
次要结局
- Time of observed peak plasma concentration(4 weeks)
- Peak plasma concentration(4 weeks)
- Area under the plasma concentration versus time curve(4 weeks)
研究者
研究点 (5)
Loading locations...
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