Pharmacokinetics of GH001 in Healthy Volunteers

A Phase 1 Study to Determine the Pharmacokinetics and Pharmacodynamics of Single and Multiple Inhaled Doses 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.

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.