Safety and Pharmacokinetics of GH002 in Healthy Volunteers

Summary

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.

Timeline

Start

2022-12-22

Primary completion

2023-11-29

Completion

2023-11-29

Drugs

Indications

No indication recorded.