Safety and Pharmacokinetics of GH002 in Healthy Volunteers

This trial (n=64) aims to investigate the safety and serum pharmacokinetics of 5-MeO-DMT in healthy volunteers. The study design is a double-blind, placebo-controlled, randomized design with single, injected doses of GH002 and an open-label, non-randomized study design with intra-subject dose-escalation of GH002.

Topic Healthy Subjects
Compound 5-MeO-DMT
Country Netherlands
Visit trial
Status Planned
Results Published No
Start date 01 March 2023
End date 01 August 2023
Chance of happening 100%
Phase Phase I
Design Blinded
Type Interventional
Generation First Second
Participants 64
Sex All
Age 18- 45
Therapy No

Trial Details

The primary objectives of this study are to investigate the safety and serum pharmacokinetics of 5-MeO-DMT in healthy volunteers in a double-blind, placebo-controlled, randomized study design with single, injected doses of GH002 and in an open-label, non-randomized study design with intra-subject dose-escalation of GH002. As secondary objectives, the PK/ pharmacodynamic relationship, PD profile of GH002 as evaluated by its psychoactive effects and impact on cognitive performance, and the serum PK of the metabolite bufotenine are also assessed.

NCT Number NCT05753956

Sponsors & Collaborators

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

Data attribution

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