A Phase 1 Dose-ranging Study of GH001 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- The safety and tolerability of GH001
研究概览
简要总结
The aim of the study is to investigate the safety of GH001 (containing 5-methoxy-dimethyltryptamine; 5-MeO-DMT), and its dose-related psychoactive effects in healthy volunteers.
The study will evaluate single, ascending doses of GH001 in Part A and an individualized dosing regimen of GH001 in Part B.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject has a body mass index (BMI) in the range of 18.5 and 27.0 kg/m2 (inclusive);
- •Subject is in good general health in the opinion of the medical supervisor;
- •Subject is in good mental health in the opinion of the (clinical) psychologist as determined by the intake interview;
排除标准
- •Has known allergies or hypersensitivity or any other contraindication to 5-MeO-DMT;
- •Has received any investigational medication within the last 1 month.
- •Has a medically significant condition, which renders the subject unsuitable for the study.
研究组 & 干预措施
GH001 dose C
干预措施: 5 Methoxy N,N Dimethyltryptamine (Drug)
GH001 dose A
干预措施: 5 Methoxy N,N Dimethyltryptamine (Drug)
GH001 dose B
干预措施: 5 Methoxy N,N Dimethyltryptamine (Drug)
GH001 dose D
干预措施: 5 Methoxy N,N Dimethyltryptamine (Drug)
GH001 Individualized Dosing
干预措施: 5 Methoxy N,N Dimethyltryptamine (Drug)
结局指标
主要结局
The safety and tolerability of GH001
时间窗: up to 7 days
The safety and tolerability of GH001 is judged by the Study Safety Group based on a combined analysis of reported adverse events, clinical observation, and safety laboratory analyses.
The dose-related psychoactive effects of GH001 as evaluated by a Visual Analogue Scale
时间窗: Retrospectively assessed at 3 hours
Visual Analogue Scale scored from 0-100
次要结局
未报告次要终点