Interventional, Randomized, Double-blind, Sequential-group, Placebo-controlled, Single-ascending-dose Study Investigating the Safety, Tolerability and Pharmacokinetic and Pharmacodynamic Properties of Lu AF82422 in Healthy Non-Japanese and Japanese Subjects and in Patients With Parkinson's Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 4
- 主要终点
- Number of patients with Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
研究概览
简要总结
The purpose of this study is to investigate the safety of a single dose of Lu AF82422, how well it is tolerated, how the drug effects the body and what the body does to the drug in healthy non-Japanese and Japanese subjects and in patients with Parkinson's disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Lu AF82422
Part A:
Cohort A1, A2, and A3: 24 healthy subjects, with 8 subjects per cohort (aiming for an equal number of men and women) Cohort A4,A5,A6: 36 healthy subjects, with 6 non-Japanese subjects and 6 Japanese subjects per cohort (aiming for an equal number of men and women)
Part B:
Cohort B1, B2, B3: 24 patients with Parkinson's disease
干预措施: Lu AF82422 (Drug)
Placebo
Part A:
Cohort A1, A2, and A3: 24 healthy subjects, with 8 subjects per cohort (aiming for an equal number of men and women) Cohort A4,A5,A6: 36 healthy subjects, with 6 non-Japanese subjects and 6 Japanese subjects per cohort (aiming for an equal number of men and women)
Part B:
Cohort B1, B2, B3: 24 patients with Parkinson's disease
干预措施: Placebo (Drug)
结局指标
主要结局
Number of patients with Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
时间窗: From dosing to Day 84
Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, blood closure time and ECG parameters)
次要结局
- AUC 0-t(From dosing to Day 84)
- Cmax(From dosing to Day 84)
- CL(From dosing to Day 84)