NCT05753956

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: GH Research Ireland Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	5 Methoxy N,N Dimethyltryptamine	GH002 administered via i.v. bolus injection(s)
DRUG	Placebo	GH002 placebo administered via i.v. bolus injection

Timeline

• Start date: 2022-12-22
• Primary completion: 2023-11-29
• Completion: 2023-11-29
• First posted: 2023-03-03
• Last updated: 2024-01-25

Locations

1 site across 1 country: Netherlands