Safety of GH001 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: 5 Methoxy N,N Dimethyltryptamine

• Registration Number: NCT04640831
• Lead Sponsor: GH Research Ireland Limited

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-13
• Primary Completion: 2019-10-04
• Study Completion: 2019-10-04
• Study First Submitted: 2020-11-12
• Study First Submitted QC: 2020-11-18
• Study First Posted: 2020-11-23
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-11
• Last Update Posted: 2023-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
GH001 Individualized Dosing	5 Methoxy N,N Dimethyltryptamine	-
GH001 dose C	5 Methoxy N,N Dimethyltryptamine	-
GH001 dose A	5 Methoxy N,N Dimethyltryptamine	-
GH001 dose B	5 Methoxy N,N Dimethyltryptamine	-
GH001 dose D	5 Methoxy N,N Dimethyltryptamine	-

Primary Outcome Measures

Name	Time	Method
The safety and tolerability of GH001	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.
The dose-related psychoactive effects of GH001 as evaluated by a Visual Analogue Scale	Retrospectively assessed at 3 hours	Visual Analogue Scale scored from 0-100

Trial Locations

Locations (1)

Clinical Trial Site; 🇳🇱 Maastricht, Netherlands