Safety and Pharmacokinetics of GH002 in Healthy Volunteers

About This Study

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.

Conditions Studied

Interventions

• •5 Methoxy N,N Dimethyltryptamine
• •Placebo

Eligibility

Inclusion Criteria:

* Has a body mass index (BMI) in the range of 18.5 and 35 kg/m2 (inclusive) at Screening.
* Is deemed in good physical health by the investigator.
* Is in good mental health in the opinion of the investigator and clinical psychologist

Exclusion Criteria:

* Has known allergies or hypersensitivity or any other contra-indication to 5-MeO-DMT.
* Has received any investigational medication, including investigational vaccines, within the 6 weeks prior to baseline
* Has a current or past clinically significant condition, which renders the subject unsuitable for the trial according to the Investigator's judgement.

Study Locations (1)