Safety of GH001 in Healthy Volunteers

GH Research Ireland Limited22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

5 Methoxy N,N DimethyltryptamineDRUG

GH001 administered via inhalation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Clinical Trial Site

Maastricht, Netherlands

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: Retrospectively assessed at 3 hours

Data from ClinicalTrials.gov

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