clinical trial · NCT05753956
Safety and Pharmacokinetics of GH002 in Healthy Volunteers
GH Research Ireland Limited·phase1·completed·n = 64
Healthy Volunteers5 Methoxy N,N DimethyltryptaminePlacebo
brief 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.
started
Dec 22, 2022
primary completion
Nov 29, 2023
completion
Nov 29, 2023
last updated
Jan 25, 2024
official title
A Phase 1 Clinical Trial to Determine the Safety, Pharmacokinetics and Pharmacodynamics of Intravenous GH002 in Healthy Volunteers
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol