Single-center, Double-blind, Placebo-controlled, Randomized, Single-ascending Dose Study to Investigate the Tolerability, Safety, Pharmacokinetics (Including Food Effect), and Pharmacodynamics of an Oral Drug for Neurological Disorders in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events (AEs)
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 male 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent
- •Healthy on the basis of physical examination, electrocardiogram and laboratory tests.
- •A subject who has a female partner of childbearing potential or a pregnant partner agrees to use a condom in combination with spermicide or a condom, respectively, from screening, during the entire study, and for at least 3 months after (the last) study drug intake
- •Body mass index (BMI) of 18.0 to 29.9 kg/m2 (inclusive) at screening and Day -
- •Systolic blood pressure (SBP) 100-140 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and pulse rate 50-90 bpm (inclusive), measured after 5 min in the supine position at screening and at Day -1.
排除标准
- •History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the study treatment
- •Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions
- •Any cardiac condition or illness with a potential to increase the cardiac risk of the subject based on medical history, physical examination, or electrocardiogram (ECG) evaluations
- •Any circumstances or conditions, which, in the opinion of the Investigator, may affect full participation in the study or compliance with the protocol
研究组 & 干预措施
AC-083, Single Ascending Dose
AC-083 administered at different single dose levels in a sequential manner, and in a maximum of 9 dose levels starting from 1 mg (number of cohorts and dose levels will depend on the safety and pharmacokinetic results of the previous cohort). Each dose level will be investigated in a new group of 8 healthy male subjects (6 on active drug and 2 on placebo)
干预措施: AC-083 (Drug)
Placebo, Single Ascending Dose
Matched placebo administered as single ascending doses in parallel to AC-083
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with adverse events (AEs)
时间窗: From baseline to end of study (EOS) (up to Day 12)
Treatment-emergent AEs and treatment emergent serious AEs
Changes from baseline in supine blood pressure
时间窗: From baseline to EOS (up to Day 12)
Supine blood pressure (mmHg)
Changes from baseline in electrocardiogram (ECG) variables
时间窗: From baseline to EOS (up to Day 12)
ECG variables are to be recorded at rest using a standard 12-lead ECG
Changes from baseline in pulse rate
时间窗: From baseline to EOS (up to Day 12)
Pulse rate (bpm)
次要结局
- Maximum plasma concentration (Cmax) following single oral ascending doses(From pre-dose on Day 1 to up to Day 12)
- Time to reach Cmax (tmax) following single oral ascending doses(From pre-dose on Day 1 to up to Day 12)
- Terminal half-life [t(1/2)] following single oral ascending doses(From pre-dose on Day 1 to up to Day 12)
- Area under the plasma concentration-time curve (AUC) following single oral ascending doses(From pre-dose on Day 1 to up to Day 12)