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Safety of GH001 in Healthy Volunteers

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The aim of the study is to investigate the safety of GH001 (containing 5-methoxy-dimethyltryptamine; 5-MeO-DMT), and its dose-related psychoactive effects in healthy volunteers.

Details

Phase I, non-randomised sequential study in healthy volunteers evaluating single ascending doses (Part A) and an individualized dosing regimen (Part B) of inhaled GH001 (5‑MeO‑DMT).

Primary outcomes focus on safety and dose-related psychoactive effects; 22 participants enrolled across four ascending-dose groups and one individualized-dosing group.

Topics:Healthy Volunteers

Registry

Registry linkNCT04640831