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CompletedPhase 1

Safety of GH001 in Healthy Volunteers

NCT04640831 · GH Research Ireland Limited

Closed to entry
Status
Not accepting participants
Phase 1
Phase
22
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • The safety and tolerability of GH001

    Measured over up to 7 days

  • The dose-related psychoactive effects of GH001 as evaluated by a Visual Analogue Scale

    Measured over Retrospectively assessed at 3 hours

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 45 Years
Ages
All
Sex
Accepted
Healthy volunteers
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.

Where

1 study site

FacilityCityRegionCountry
Clinical Trial SiteMaastrichtNetherlands

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT04640831 on ClinicalTrials.gov →

Last updated in the registry 2023-08-15. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits