Single-center, Double-blind, Randomized, Placebo-controlled, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics (Including Food Effect), and Pharmacodynamics of an Oral Drug for Neurological Disorders in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Changes from baseline in vital signs
研究概览
简要总结
The primary purpose of this first-in-man study is to investigate whether a new drug for neurological disorders is safe and well-tolerated when administered orally to healthy adults
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（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
AC-082, Single Ascending Dose
Subjects receive AC-082 at different single dose levels in a sequential manner, starting from 10 mg (number of cohorts and dose levels will depend on the safety and pharmacokinetic results of the previous cohort). Each subject can participate in only one dose level
干预措施: AC-082 (Drug)
Placebo, Single Ascending Dose
Subjects receive a single dose of the matched placebo
干预措施: Placebo (Drug)
AC-082, Multiple Ascending Dose
Subjects receive AC-082 at different dose levels for 4 consecutive days in a sequential manner (dose levels and duration to be adapted according to the results of the single ascending dose cohorts). Each subject can participate in only one dose level
干预措施: AC-082 (Drug)
Placebo, Multiple Ascending Dose
Subjects receive the matched placebo for 4 days
干预措施: Placebo (Drug)
结局指标
主要结局
Changes from baseline in vital signs
时间窗: Up to end of study (up to Day 11)
Vital signs include diastolic and systolic blood pressure and pulse rate
Changes from baseline in ECG variables
时间窗: Up to end of study (up to day 11)
ECG variables are to be recorded at rest using a standard 12-lead ECG
Number of participants with adverse events (AEs)
时间窗: Up to end of study (up to Day 11)
Treatment-emergent adverse events and treatment-emergent serious adverse events
次要结局
- Maximum plasma concentration (Cmax) following single ascending doses(From pre-dose on Day 1 to 96 hours post dose)
- Time to reach Cmax (tmax) following single ascending doses(From pre-dose on Day 1 to 96 hours post dose)
- Terminal half-life [t(1/2)] following single ascending doses(From pre-dose on Day 1 to 96 hours post dose)
- Area under the plasma concentration-time curve (AUC) following single ascending doses(From pre-dose on Day 1 to 96 hours post dose)
- Maximum plasma concentration (Cmax) following multiple ascending doses(Up to 96 hours following the last dose administration on Day 4)
- Time to reach Cmax (tmax) following multiple ascending doses(Up to 96 hours following the last dose administration on Day 4)
- Terminal half-life [t(1/2)] following multiple ascending doses(Up to 96 hours following the last dose administration on Day 4)
- Area under the plasma concentration-time curve during a dosing interval (AUCtau)(Day 1 and Day 4)