A Phase 1 Clinical Trial to Determine the Safety, Pharmacokinetics and Pharmacodynamics of Intravenous GH002 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 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
研究概览
简要总结
The primary objectives of this study are to investigate the safety and serum pharmacokinetics of 5-MeO-DMT in healthy volunteers in a double-blind, placebo-controlled, randomized study design with single, injected doses of GH002 and in an open-label, non-randomized study design with intra-subject dose-escalation of GH002. As secondary objectives, the PK/ pharmacodynamic relationship, PD profile of GH002 as evaluated by its psychoactive effects and impact on cognitive performance, and the serum PK of the metabolite bufotenine 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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Has a body mass index (BMI) in the range of 18.5 and 35 kg/m2 (inclusive) at Screening.
- •Is deemed in good physical health by the investigator.
- •Is in good mental health in the opinion of the investigator and clinical psychologist
排除标准
- •Has known allergies or hypersensitivity or any other contra-indication to 5-MeO-DMT.
- •Has received any investigational medication, including investigational vaccines, within the 6 weeks prior to baseline
- •Has a current or past clinically significant condition, which renders the subject unsuitable for the trial according to the Investigator's judgement.
研究组 & 干预措施
Cohort A: Dose A single dose
A single dose of GH002 or placebo administered by i.v. bolus injection (randomized as 6 active and 2 placebo subjects)
干预措施: 5 Methoxy N,N Dimethyltryptamine (Drug)
Cohort E: Dose E single dose
A single dose of GH002 or placebo administered by i.v. bolus injection (randomized as 6 active and 2 placebo subjects)
干预措施: Placebo (Drug)
Cohort A: Dose A single dose
A single dose of GH002 or placebo administered by i.v. bolus injection (randomized as 6 active and 2 placebo subjects)
干预措施: Placebo (Drug)
Cohort B: Dose B single dose
A single dose of GH002 or placebo administered by i.v. bolus injection (randomized as 6 active and 2 placebo subjects)
干预措施: 5 Methoxy N,N Dimethyltryptamine (Drug)
Cohort B: Dose B single dose
A single dose of GH002 or placebo administered by i.v. bolus injection (randomized as 6 active and 2 placebo subjects)
干预措施: Placebo (Drug)
Cohort C: Dose C single dose
A single dose of GH002 or placebo administered by i.v. bolus injection (randomized as 6 active and 2 placebo subjects)
干预措施: 5 Methoxy N,N Dimethyltryptamine (Drug)
Cohort C: Dose C single dose
A single dose of GH002 or placebo administered by i.v. bolus injection (randomized as 6 active and 2 placebo subjects)
干预措施: Placebo (Drug)
Cohort D: Dose D single dose
A single dose of GH002 or placebo administered by i.v. bolus injection (randomized as 6 active and 2 placebo subjects)
干预措施: 5 Methoxy N,N Dimethyltryptamine (Drug)
Cohort D: Dose D single dose
A single dose of GH002 or placebo administered by i.v. bolus injection (randomized as 6 active and 2 placebo subjects)
干预措施: Placebo (Drug)
Cohort E: Dose E single dose
A single dose of GH002 or placebo administered by i.v. bolus injection (randomized as 6 active and 2 placebo subjects)
干预措施: 5 Methoxy N,N Dimethyltryptamine (Drug)
Cohort F: Dose F single dose
A single dose of GH002 or placebo administered by i.v. bolus injection (randomized as 6 active and 2 placebo subjects)
干预措施: 5 Methoxy N,N Dimethyltryptamine (Drug)
Cohort F: Dose F single dose
A single dose of GH002 or placebo administered by i.v. bolus injection (randomized as 6 active and 2 placebo subjects)
干预措施: Placebo (Drug)
Cohort G: Dose G single dose
A single dose of GH002 or placebo administered by i.v. bolus injection (randomized as 6 active and 2 placebo subjects)
干预措施: 5 Methoxy N,N Dimethyltryptamine (Drug)
Cohort G: Dose G single dose
A single dose of GH002 or placebo administered by i.v. bolus injection (randomized as 6 active and 2 placebo subjects)
干预措施: Placebo (Drug)
Cohort J: Individualized Dosing Regimen
Administration of up to 3 doses of GH002 within a single day (doses to be confirmed following review of data from single-dose part)
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
时间窗: Up to 6 hours
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH002 to determine 5-MeO-DMT serum concentrations.
Safety and tolerability: local tolerance (injection site reactions)
时间窗: Up to discharge on dosing day
Local infusion site findings will be assessed as none, mild, moderate and severe for the following signs and symptoms of the applicable site: dryness, redness, swelling, pain, tenderness, and itching and other.
Safety and tolerability: Assessment of subject-discharge readiness at discharge on Day 0
时间窗: Up to discharge on dosing day
Assessment of Discharge Readiness on the administration day by the Principal Investigator, using the Clinical Assessment of Discharge Readiness (CADR).
Safety and tolerability: incidence of treatment emergent adverse events
时间窗: Up to 7 days
Adverse events reported in the study and coded by MedDRA.
Safety and tolerability: Clinically significant changes from baseline in ECG, vital signs and safety laboratory assessments
时间窗: Up to 7 days
Clinically significant changes in ECG include any significant change in rate or rhythm as determined by the principal investigator
Safety and tolerability: Assessment of sedation (Modified Observer's Assessment of Alertness and Sedation [MOAA/S]) following each dose and as part of the discharge evaluation on Day 0
时间窗: Up to discharge on dosing day
The Modified Observer's Assessment of Alertness and Sedation scale (MOAA/S) will be completed before and after GH002 dosing. Scored from 0 (deep sedation) to 5 (alert)
Safety and tolerability: Columbia-Suicide Severity Rating Scale (C-SSRS) categorization based on the Columbia Classification Algorithm of Suicide Assessment (C-CASA).
时间窗: Up to 7 days
A detailed questionnaire assessing both suicidal behaviour and suicidal ideation.
Safety and tolerability: Change from baseline in Brief Psychiatric Rating Scale (BPRS).
时间窗: Up to 7 days
A scale to measure psychiatric symptoms. Each symptom is rated 1-7 and a total of 18 symptoms are scored. Combined score ranges from 18 to 126.
Safety and tolerability: Change from baseline in Clinician Administered Dissociative States Scale (CADSS)
时间窗: Up to 7 days
The CADSS comprises 19 subjective items, ranging from 0 'not at all' to 4 'extremely. Summed together, these subscales form a total dissociative score. Combined score ranges from 0 to 76
次要结局
- Pharmacodynamic assessment: The dose-related psychoactive effects of GH002 as evaluated by a Visual Analogue Scale(Up to 1 hour after dosing)
- PK/PD relationship(s) of 5-MeO-DMT(Up to 1 hour after dosing)
- Pharmacodynamic assessment: Challenging Experiences Questionnaire (CEQ)(Up to 1 hour after dosing)
- Pharmacodynamic assessment: 30-Question Mystical Experience Questionnaire (MEQ30)(Up to 1 hour after dosing)
- Pharmacodynamic assessment: Duration of the psychoactive effects (PsE)(Up to 1 hour after dosing)
- Cognitive Function: Change from baseline in Verbal recognition memory (VRM) test(Up to 7 days)
- Cognitive Function: Change from baseline in Rapid visual information processing (RVP) test(Up to 7 days)
- The pharmacokinetic (PK) parameters derived from laboratory assay results of the systemic levels of bufotenine(Up to 6 hours)
- Cognitive Function: Change from baseline in Spatial Working Memory (SWM) task(Up to 7 days)
- Cognitive Function: Change from baseline in Digit Symbol Substitution Task (DSST)(Up to 7 days)