Safety of GH001 in Healthy Volunteers

NCT04640831 | Completed Phase 1

• 2 other identifiers: GH001-HV-1012018-003632-68
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

healthy volunteers; 5-MeO-DMT; 5-methoxy-dimethyltryptamine

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (5)

GH001 dose A

EXPERIMENTAL

Drug: 5 Methoxy N,N Dimethyltryptamine

GH001 dose B

EXPERIMENTAL

Drug: 5 Methoxy N,N Dimethyltryptamine

GH001 dose C

EXPERIMENTAL

Drug: 5 Methoxy N,N Dimethyltryptamine

GH001 dose D

EXPERIMENTAL

Drug: 5 Methoxy N,N Dimethyltryptamine

GH001 Individualized Dosing

EXPERIMENTAL

Drug: 5 Methoxy N,N Dimethyltryptamine

Interventions

5 Methoxy N,N Dimethyltryptamine DRUG

GH001 administered via inhalation

Also known as: GH001, 5-MeO-DMT

GH001 Individualized Dosing; GH001 dose A; GH001 dose B; GH001 dose C; GH001 dose D

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• GH Research Ireland Limited: lead

Study Sites (1)

Clinical Trial Site

Maastricht, Netherlands

Location

Related Publications (1)

• Reckweg J, Mason NL, van Leeuwen C, Toennes SW, Terwey TH, Ramaekers JG. A Phase 1, Dose-Ranging Study to Assess Safety and Psychoactive Effects of a Vaporized 5-Methoxy-N, N-Dimethyltryptamine Formulation (GH001) in Healthy Volunteers. Front Pharmacol. 2021 Nov 25;12:760671. doi: 10.3389/fphar.2021.760671. eCollection 2021.

  PMID: 34912222 RESULT

MeSH Terms

Interventions

Methoxydimethyltryptamines

Intervention Hierarchy (Ancestors)

N,N-Dimethyltryptamine; Tryptamines; Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Bufotenin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Serotonin

Study Officials

• GH Research Clinical Team

  GH Research Ireland Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part A: Dose ranging in four dose groups Part B: One group with individualized dosing

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: November 23, 2020
• Study Start: March 13, 2019
• Primary Completion: October 4, 2019
• Study Completion: October 4, 2019
• Last Updated: August 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)