A Phase 1 Study to Determine the Pharmacokinetics and Pharmacodynamics of Single and Multiple Inhaled Doses of GH001 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- The pharmacokinetic (PK) parameters derived from laboratory assay results of the systemic levels of 5-MeO-DMT and bufotenine
研究概览
简要总结
The primary objective of this study is to investigate the serum pharmacokinetics of 5-MeO-DMT and its metabolite, bufotenine in healthy volunteers in a double-blind, placebo-controlled, randomized study design with single, inhaled doses of GH001 and in an open-label, non-randomized study design with intra-subject dose-escalation of GH001. As a secondary objective, the safety and tolerability of GH001, the mental health and well-being of the subjects after GH001 dosing(s), the pharmacodynamic profile of GH001 as evaluated by its psychoactive effects, and cognitive measures are also assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 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 35.0 kg/m2 (inclusive);
- •Subject is in good physical health in the opinion of the principal investigator (PI);
- •Subject is in good mental health in the opinion of the PI and clinical psychologist;
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 4 weeks;
- •Has a medical condition, which renders the subject unsuitable for the study.
研究组 & 干预措施
Group C - 18 mg single-dose
A single, inhaled dose of GH001 18 mg or placebo (randomized as 8 active and 2 placebo subjects)
干预措施: Placebo (Drug)
Group A - 6 mg single-dose
A single, inhaled dose of GH001 6 mg or placebo (randomized as 8 active and 2 placebo subjects)
干预措施: 5 Methoxy N,N Dimethyltryptamine (Drug)
Group A - 6 mg single-dose
A single, inhaled dose of GH001 6 mg or placebo (randomized as 8 active and 2 placebo subjects)
干预措施: Placebo (Drug)
Group B - 12 mg single-dose
A single, inhaled dose of GH001 12 mg or placebo (randomized as 8 active and 2 placebo subjects)
干预措施: 5 Methoxy N,N Dimethyltryptamine (Drug)
Group B - 12 mg single-dose
A single, inhaled dose of GH001 12 mg or placebo (randomized as 8 active and 2 placebo subjects)
干预措施: Placebo (Drug)
Group C - 18 mg single-dose
A single, inhaled dose of GH001 18 mg or placebo (randomized as 8 active and 2 placebo subjects)
干预措施: 5 Methoxy N,N Dimethyltryptamine (Drug)
Group D - Individualized Dosing Regimen, 1-hour interval
Administration of up to 3 inhaled doses of GH001 within a single day (6 mg, followed by 12 mg, followed by 18 mg) with a 1-hour dose interval (8 subjects)
干预措施: 5 Methoxy N,N Dimethyltryptamine (Drug)
Group E - Individualized Dosing Regimen, 2-hour interval
Administration of up to 3 inhaled doses of GH001 within a single day (6 mg, followed by 12 mg, followed by 18 mg) with a 2-hour dose interval (8 subjects)
干预措施: 5 Methoxy N,N Dimethyltryptamine (Drug)
结局指标
主要结局
The pharmacokinetic (PK) parameters derived from laboratory assay results of the systemic levels of 5-MeO-DMT and bufotenine
时间窗: up to 4 hours
For PK analyses, blood samples will be collected before and up to 4 hours after the administration of GH001 to determine 5-MeO-DMT and bufotenine serum concentrations.
次要结局
- Safety: Frequency of clinically significant changes from baseline in electrocardiogram (ECG) recording(Up to 7 days)
- Safety: Frequency of clinically significant changes from baseline in Peak Flow Respirometry(1 hour after dosing)
- Safety: Frequency of clinically significant changes from baseline in level of sedation(30 minutes and 1 hour after dosing)
- Safety: Change from baseline in Clinician Administered Dissociative States Scale (CADSS)(Up to 30 days)
- Mental Health: Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)(Up to 30 days)
- Pharmacodynamic assessment: The dose-related psychoactive effects of GH001 as evaluated by a Visual Analogue Scale(up to 1 hour after dosing)
- Pharmacodynamic assessment: Challenging Experiences Questionnaire (CEQ)(up to 1 hour after dosing)
- Safety: Adverse Event (AE) reporting(Up to 30 days)
- Safety: Frequency of clinically significant changes from baseline in vital signs measurement(Up to 7 days)
- Pharmacodynamic assessment: Duration of the psychoactive effects (PsE)(up to 1 hour after dosing)
- Cognitive Function: Change from baseline in Psychomotor Vigilance Task (PVT)(Up to 7 days)
- Safety: Frequency of clinically significant changes from baseline in safety laboratory tests of blood and urine(Up to 7 days)
- Pharmacodynamic assessment: 30-Question Mystical Experience Questionnaire (MEQ30)(up to 1 hour after dosing)
- Cognitive Function: Change from baseline in Auditory Verbal Learning Test (AVLT)(Up to 7 days)
- Cognitive Function: Change from baseline in Spatial Working Memory (SWM) task(Up to 7 days)
- Safety: Assessment of Subject-Discharge readiness(up to 3 hours after last study drug administration)
- Mental Health: Change from baseline in Brief Psychiatric Rating Scale (BPRS)(Up to 30 days)
- Cognitive Function: Change from baseline in Digit Symbol Substitution Task (DSST)(Up to 7 days)