Safety of GH001 in Healthy Volunteers

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04640831
• Other study ID #: GH001-HV-101
• Secondary ID: 2018-003632-68
• Status: Completed
• Phase: Phase 1
• Start date: March 13, 2019
• Est. completion date: October 4, 2019

Study information

• Verified date: August 2023
• Source: GH Research Ireland Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 4, 2019
• Est. primary completion date: October 4, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• 5 Methoxy N,N Dimethyltryptamine
GH001 administered via inhalation

Locations

Country	Name	City	State
Netherlands	Clinical Trial Site	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
GH Research Ireland Limited

Country where clinical trial is conducted

Netherlands, 

References & 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. 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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