Safety 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.

Topic Healthy Subjects
Compound 5-MeO-DMT
Country Netherlands
Visit trial
Status Completed
Results Published No
Start date 13 March 2019
End date 04 October 2019
Chance of happening 100%
Phase Phase I
Design Open
Type Interventional
Generation Second
Participants 22
Sex All
Age 18- 45
Therapy No

Trial Details

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.

NCT Number NCT04640831

Sponsors & Collaborators

GH Research
GH Research is developing several 5-MeO-DMT based therapeutic mechanisms for various mental health disorders.

Papers

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
This Phase I study assessed the safety and psychoactive effects of 5-MeO-DMT (GH001) in healthy volunteers (n=22). Single doses of 6, 12, and 18 mg of the inhaled GH001 formulation of 5-MeO-DMT were able to induce a peak experience in a minority of participants. An individualized dose escalation regimen produced a peak experience in every participant. Measures of cognition, mood, and well-being were not affected by 5-MeO-DMT. Adverse events were generally mild and resolved spontaneously.

Data attribution

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