Safety of GH001 in Healthy Volunteers

Phase 1 Completed 22 enrolled GH Research Ireland Limited

Non-randomizedSequentialOpen-labelTreatment

Summary

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. The study will evaluate single, ascending doses of GH001 in Part A and an individualized dosing regimen of GH001 in Part B.

Timeline

Start: 2019-03-13
Primary completion: 2019-10-04
Completion: 2019-10-04

Publications

Results Reckweg J, Mason NL, van Leeuwen C, Toennes SW, Terwey TH, Ramaekers JG. A Phase 1, Dose-Ranging Study to Assess Safety and Psychoactive Effects of a Vaporized 5-Methoxy-N, N-Dimethyltryptamine Formulation (GH001) in Healthy Volunteers. Front Pharmacol. 2021 Nov 25;12:760671. doi: 10.3389/fphar.2021.760671. eCollection 2021.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mebufotenin	Small molecule	2 mg	Inhaled
Subject	Mebufotenin	Small molecule	6 mg	Inhaled
Subject	Mebufotenin	Small molecule	12 mg	Inhaled
Subject	Mebufotenin	Small molecule	18 mg	Inhaled

Indications

No indication recorded.