A Phase 1b, Adaptive, Multi-Center, Randomized, Double Blind, Placebo-Controlled, Parallel Design Study to Investigate The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7486967 in Participants With Early Idiopathic Parkinson's Disease
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 17
- 主要终点
- Percentage of Participants with adverse events (AEs)
研究概览
简要总结
This is a multi-center, randomized, double blind, adaptive, parallel-group, placebo controlled Phase 1b study to evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamics of RO7486967 in participants with idiopathic PD at the early stage of the disease (modified H&Y stage ≤2.5) who are either treatment-naïve or on stable treatment with symptomatic therapy (levodopa and/or pramipexole, ropinirole, rotigotine).
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
- 40 Years 至 85 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
RO7486967 Arm
Participants will receive RO07486967 for approximately 28 days with 14 days of follow up after the last dose.
干预措施: RO7486967 (Drug)
Placebo
Matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants with adverse events (AEs)
时间窗: Up to 45 Days
The change in Columbia-Suicide Severity Rating Scale (C-SSRS) Scores from baseline
时间窗: From Baseline to Up to 45 Days
次要结局
- Time to maximum concentration of RO7486967 in Plasma(Day 1, Day 15, and Day 28)
- Maximum concentration (Cmax) of RO7486967 in Plasma(Day 1, Day 15, and Day 28)
- Area under the curve (AUC) RO7486967 in Plasma(Day 1, Day 15, and Day 28)
- Change from baseline in parametric bindings of [18F]-DPA-714 in different brain areas at Day 25 PET(From Baseline to Approximately Day 25)