Safety of GH001 in Healthy Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1 Dose-ranging Study of GH001 in Healthy Volunteers

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: 5 Methoxy N,N Dimethyltryptamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Part A: Dose ranging in four dose groups Part B: One group with individualized dosing
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GH001 dose A<br> | Drug: 5 Methoxy N,N Dimethyltryptamine<br>* GH001 administered via inhalation<br>* Other names: 5-MeO-DMT;|
| Experimental: GH001 dose B<br> | Drug: 5 Methoxy N,N Dimethyltryptamine<br>* GH001 administered via inhalation<br>* Other names: 5-MeO-DMT;|
| Experimental: GH001 dose C<br> | Drug: 5 Methoxy N,N Dimethyltryptamine<br>* GH001 administered via inhalation<br>* Other names: 5-MeO-DMT;|
| Experimental: GH001 dose D<br> | Drug: 5 Methoxy N,N Dimethyltryptamine<br>* GH001 administered via inhalation<br>* Other names: 5-MeO-DMT;|
| Experimental: GH001 Individualized Dosing<br> | Drug: 5 Methoxy N,N Dimethyltryptamine<br>* GH001 administered via inhalation<br>* Other names: 5-MeO-DMT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety and tolerability of GH001 | 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. | up to 7 days | 
| The dose-related psychoactive effects of GH001 as evaluated by a Visual Analogue Scale | Visual Analogue Scale scored from 0-100 | Retrospectively assessed at 3 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healthy volunteers, 5-MeO-DMT, 5-methoxy-dimethyltryptamine