Interventional, Randomized, Double-blind, Placebo-controlled, Single-ascending-dose Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Lu AF87908 in Healthy Subjects and Patients With Alzheimer's Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 6
- 主要终点
- AUC(0-t) of Lu AF87908
研究概览
简要总结
The purpose of this study is to investigate the safety of a single dose of Lu AF87908, how well it is tolerated and what the body does to the drug in healthy participants and participants with Alzheimer's disease.
详细描述
The study will be divided into three parts: Part A, Part B and Part C.
Part A consists of up to 6 sequential cohorts (Cohorts A1 to A6):
-Cohorts A1 to A6: 8 healthy participants per cohort (aiming for an equal number of men and women): 6 randomized to Lu AF87908 and 2 randomized to placebo.
Part B consists of up to 3 sequential cohorts (Cohorts B1 to B3):
-Cohorts B1 to B3: 4 Japanese and 4 Chinese healthy participants per cohort: 6 participants randomized to Lu AF87908 and 2 participants randomized to placebo.
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 65 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
Part B: Lu AF87908 or Placebo
Participants in Cohorts B1 to B3 will receive a single dose of either Lu AF87908 or matching placebo at specific dose levels on Day 1.
干预措施: Lu AF87908 (Drug)
Part A: Lu AF87908 or Placebo
Participants in Cohorts A1 to A6 will receive a single dose of either Lu AF87908 or matching placebo at specific dose levels on Day 1.
干预措施: Lu AF87908 (Drug)
Part A: Lu AF87908 or Placebo
Participants in Cohorts A1 to A6 will receive a single dose of either Lu AF87908 or matching placebo at specific dose levels on Day 1.
干预措施: Placebo (Drug)
Part B: Lu AF87908 or Placebo
Participants in Cohorts B1 to B3 will receive a single dose of either Lu AF87908 or matching placebo at specific dose levels on Day 1.
干预措施: Placebo (Drug)
Part C: Lu AF87908 or Placebo
Participants in Cohorts C1 and C4 will receive a single dose of either Lu AF87908 or matching placebo at specific dose levels on Day 1.
干预措施: Lu AF87908 (Drug)
Part C: Lu AF87908 or Placebo
Participants in Cohorts C1 and C4 will receive a single dose of either Lu AF87908 or matching placebo at specific dose levels on Day 1.
干预措施: Placebo (Drug)
结局指标
主要结局
AUC(0-t) of Lu AF87908
时间窗: From Day 0 to Day 84
Area under the plasma concentration curve for Lu AF87908
Tmax Lu AF87908
时间窗: From Day 0 to Day 84
Nominal time of occurrence of Cmax of Lu AF97908 in plasma
Number of Participants with Treatment Emergent Adverse Events
时间窗: From Day 0 to Day 84
Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, ECG parameters and physical examination)
Cmax of Lu AF87908
时间窗: From Day 0 to Day 84
Maximum observed plasma concentration for Lu AF87908
次要结局
未报告次要终点