CompletedPhase 1

Safety and Pharmacokinetics of GH002 in Healthy Volunteers

NCT05753956 · GH Research Ireland Limited

Closed to entry

Status

Not accepting participants

Phase 1

Phase

Target enrolment

Study sites

Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

Safety and tolerability: incidence of treatment emergent adverse events
Measured over Up to 7 days
Safety and tolerability: local tolerance (injection site reactions)
Measured over Up to discharge on dosing day
Safety and tolerability: Clinically significant changes from baseline in ECG, vital signs and safety laboratory assessments
Measured over Up to 7 days
Safety and tolerability: Assessment of sedation (Modified Observer's Assessment of Alertness and Sedation [MOAA/S]) following each dose and as part of the discharge evaluation on Day 0
Measured over Up to discharge on dosing day
Safety and tolerability: Change from baseline in Clinician Administered Dissociative States Scale (CADSS)
Measured over Up to 7 days
Safety and tolerability: Assessment of subject-discharge readiness at discharge on Day 0
Measured over Up to discharge on dosing day
Safety and tolerability: Columbia-Suicide Severity Rating Scale (C-SSRS) categorization based on the Columbia Classification Algorithm of Suicide Assessment (C-CASA).
Measured over Up to 7 days
Safety and tolerability: Change from baseline in Brief Psychiatric Rating Scale (BPRS).
Measured over Up to 7 days
The pharmacokinetic (PK) parameters derived from laboratory assay results of the systemic levels of 5-MeO-DMT
Measured over Up to 6 hours

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 45 Years

Ages

All

Sex

Accepted

Healthy volunteers

Inclusion Criteria: * Has a body mass index (BMI) in the range of 18.5 and 35 kg/m2 (inclusive) at Screening. * Is deemed in good physical health by the investigator. * Is in good mental health in the opinion of the investigator and clinical psychologist Exclusion Criteria: * Has known allergies or hypersensitivity or any other contra-indication to 5-MeO-DMT. * Has received any investigational medication, including investigational vaccines, within the 6 weeks prior to baseline * Has a current or past clinically significant condition, which renders the subject unsuitable for the trial according to the Investigator's judgement.

Where

1 study site

Facility	City	Region	Country
GH Research Clinical Trial Site	Groningen	—	Netherlands

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05753956 on ClinicalTrials.gov →

Last updated in the registry 2024-01-25. Registry records change; this page reflects the data build of 2026-08-25.

Where this trial sits

Substance

All 9 trials from GH Research Ireland Limited →