Safety of GH001 in Healthy Volunteers

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trial Site

Maastricht, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

5 Methoxy N,N Dimethyltryptamine

Drug

GH001 administered via inhalation

Other names: GH001, 5-MeO-DMT

Primary outcomes

The safety and tolerability of GH001

Time frame: 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

Time frame: Retrospectively assessed at 3 hours

Visual Analogue Scale scored from 0-100

Sponsors and collaborators

Lead sponsor

GH Research Ireland Limited

Industry

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: Nov 23, 2020
Registry last updated: Aug 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed