Safety and Pharmacokinetics of GH002 in Healthy Volunteers

A Phase 1 Clinical Trial to Determine the Safety, Pharmacokinetics and Pharmacodynamics of Intravenous GH002 in Healthy Volunteers

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.

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.