Pharmacokinetics of GH001 in Healthy Volunteers

The primary objective of this study is to investigate the serum pharmacokinetics of 5-MeO-DMT and its metabolite, bufotenine in healthy volunteers in a double-blind, placebo-controlled, randomized study design with single, inhaled doses of GH001 and in an open-label, non-randomized study design with intra-subject dose-escalation of GH001.

As a secondary objective, the safety and tolerability of GH001, the mental health and well-being of the subjects after GH001 dosing(s), the pharmacodynamic profile of GH001 as evaluated by its psychoactive effects, and cognitive measures are also assessed.

Status Completed
Results Published
Start date 21 June 2021
End date 22 November 2021
Chance of happening 100%
Phase Phase I
Design Blinded
Type Interventional
Generation Second
Participants 46
Sex All
Age 18- 64
Therapy No

Trial Details

The primary objective of this study is to investigate the serum pharmacokinetics of 5-MeO-DMT and its metabolite, bufotenine in healthy volunteers in a double-blind, placebo-controlled, randomized study design with single, inhaled doses of GH001 and in an open-label, non-randomized study design with intra-subject dose-escalation of GH001. As a secondary objective, the safety and tolerability of GH001, the mental health and well-being of the subjects after GH001 dosing(s), the pharmacodynamic profile of GH001 as evaluated by its psychoactive effects, and cognitive measures are also assessed.

NCT Number NCT05163691

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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