Safety of GH001 in Healthy Volunteers

GH Research

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: 5 Methoxy N,N Dimethyltryptamine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04640831

2018-003632-68 (EudraCT Number)

GH001-HV-101

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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22 participants in 5 patient groups

GH001 dose A

Experimental group

Treatment:

Drug: 5 Methoxy N,N Dimethyltryptamine

GH001 dose B

Experimental group

Treatment:

Drug: 5 Methoxy N,N Dimethyltryptamine

GH001 dose C

Experimental group

Treatment:

Drug: 5 Methoxy N,N Dimethyltryptamine

GH001 dose D

Experimental group

Treatment:

Drug: 5 Methoxy N,N Dimethyltryptamine

GH001 Individualized Dosing

Experimental group

Treatment:

Drug: 5 Methoxy N,N Dimethyltryptamine