Pharmacokinetics of GH001 in Healthy Volunteers

About This Study

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.

Conditions Studied

Interventions

• •5 Methoxy N,N Dimethyltryptamine
• •Placebo

Eligibility

Inclusion Criteria:

* Subject has a body mass index (BMI) in the range of 18.5 and 35.0 kg/m2 (inclusive);
* Subject is in good physical health in the opinion of the principal investigator (PI);
* Subject is in good mental health in the opinion of the PI and clinical psychologist;

Exclusion Criteria:

* Has known allergies or hypersensitivity or any other contraindication to 5-MeO-DMT;
* Has received any investigational medication within the last 4 weeks;
* Has a medical condition, which renders the subject unsuitable for the study.

Study Locations (1)