Safety of GH001 in Healthy Volunteers

August 11, 2023 updated by: GH Research Ireland Limited

A Phase 1 Dose-ranging Study 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands
        • Clinical Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GH001 dose A
Drug: 5 Methoxy N,N Dimethyltryptamine
GH001 administered via inhalation
Other Names:
  • GH001
  • 5-MeO-DMT
Experimental: GH001 dose B
Drug: 5 Methoxy N,N Dimethyltryptamine
GH001 administered via inhalation
Other Names:
  • GH001
  • 5-MeO-DMT
Experimental: GH001 dose C
Drug: 5 Methoxy N,N Dimethyltryptamine
GH001 administered via inhalation
Other Names:
  • GH001
  • 5-MeO-DMT
Experimental: GH001 dose D
Drug: 5 Methoxy N,N Dimethyltryptamine
GH001 administered via inhalation
Other Names:
  • GH001
  • 5-MeO-DMT
Experimental: GH001 Individualized Dosing
Drug: 5 Methoxy N,N Dimethyltryptamine
GH001 administered via inhalation
Other Names:
  • GH001
  • 5-MeO-DMT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 7 days
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
Retrospectively assessed at 3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GH Research Ireland Limited

Investigators

  • Study Director: GH Research Clinical Team, GH Research Ireland Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2019

Primary Completion (Actual)

October 4, 2019

Study Completion (Actual)

October 4, 2019

Study Registration Dates

First Submitted

November 12, 2020

First Submitted That Met QC Criteria

November 18, 2020

First Posted (Actual)

November 23, 2020

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 11, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GH001-HV-101
  • 2018-003632-68 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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