Assessment of Safety, Tolerability and Pharmacokinetics of Single Doses of Oral Dexanabinol in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Safety and Tolerability Based on the Number of Participants With Adverse Events and Comparison of Baseline and Post Dose Parameters
研究概览
简要总结
The purpose of this study is to test the safety and observe the pharmacokinetics (distribution and elimination of the drug) of the compound dexanabinol (ETS2101) in healthy male subjects following a single oral dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, 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
- •Healthy males aged 18 to 45 years
- •Body mass index 18.0 to 32.0 kg/m2, or if outside the range, considered not clinically significant by the investigator
排除标准
- •Participation in a clinical research study within the previous 3 months
- •Current smokers and those who have smoked within the last 12 months
- •History of any drug or alcohol abuse in the past 2 years
研究组 & 干预措施
Placebo
Single oral dose of matching placebo
干预措施: Placebo (Drug)
Dexanabinol Dose Level 1
Single oral dose of dexanabinol
干预措施: Dexanabinol Dose Level 1 (Drug)
Dexanabinol Dose Level 2
Single oral dose of dexanabinol
干预措施: Dexanabinol Dose Level 2 (Drug)
Dexanabinol Dose Level 3
Single oral dose of dexanabinol
干预措施: Dexanabinol Dose Level 3 (Drug)
Dexanabinol Dose Level 4
Single oral dose of dexanabinol
干预措施: Dexanabinol Dose Level 4 (Drug)
Dexanabinol Dose Level 5
Single oral dose of dexanabinol
干预措施: Dexanabinol Dose Level 5 (Drug)
结局指标
主要结局
Safety and Tolerability Based on the Number of Participants With Adverse Events and Comparison of Baseline and Post Dose Parameters
时间窗: Participants will be followed until follow up visit, 6-11 days after dosing
Safety and tolerability based on the number of participants with adverse events. Assessment and comparison to baseline of the following: * Physical exam * Safety bloods and urinalysis * 12-lead ECG * Vital signs
次要结局
- Area Under the Curve of the Compound Dexanabinol (ETS2101) From Pre-dose up to 48 Hours Post Dose(Pre-dose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16,24,36,48 hours post dose)