RecruitingPhase 1

Pharmacokinetics of GH001 Delivered Via a Proprietary Aerosol Delivery Device in Healthy Subjects

NCT06511947 · GH Research Ireland Limited

Recruiting

Status

Accepting participants

Phase 1

Phase

Target enrolment

Study sites

Outside the US

What it is testing

Summary

The primary objectives of this trial are to determine the pharmacokinetic (PK) profile and the safety and tolerability of GH001 delivered via a proprietary aerosol delivery device in healthy subjects after single-dose administration and a single-day individualized dosing regimen (IDR). As secondary objectives, the mebufotenin PK/ pharmacodynamic (PD) relationship, the PD profile of GH001 as evaluated by its psychoactive effects (PsE), the impact on cognitive performance, and the TCmax/2 and TCmax/10 (time taken for Cmax to decrease by 50 and 90%, respectively) 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

Serum PK parameters of mebufotenin - maximum observed concentration (Cmax)
Measured over Up to 6 hours
Serum PK parameters of mebufotenin - time of maximum observed concentration (Tmax)
Measured over Up to 6 hours
Serum PK parameters of mebufotenin - terminal elimination half-life (t1/2)
Measured over Up to 6 hours
Serum PK parameters of mebufotenin - area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUC0-t)
Measured over Up to 6 hours
Serum PK parameters of mebufotenin - area under the serum concentration-time curve extrapolated to infinity (AUC0-∞)
Measured over Up to 6 hours
Serum PK parameters of mebufotenin - terminal elimination rate constant (λz)
Measured over Up to 6 hours
Serum PK parameters of mebufotenin - apparent total body clearance (CL/F)
Measured over Up to 6 hours
Serum PK parameters of mebufotenin - apparent steady-state volume of distribution (VSS/F)
Measured over Up to 6 hours
Serum PK parameters of mebufotenin - Cmax/AUC0-∞
Measured over Up to 6 hours
Safety and tolerability: incidence of treatment-emergent adverse events
Measured over Up to 7 days
Safety and tolerability: clinically significant changes from baseline in electrocardiogram (ECG), vital signs, spirometry 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 Postdose, up to discharge on dosing day (Day 0)
Safety and tolerability: change from baseline in Clinician Administered Dissociative States Scale (CADSS)
Measured over From baseline up to 7 days
Safety and tolerability: assessment of subject discharge readiness at discharge on Day 0
Measured over Postdose, at discharge on dosing day (Day 0)
Safety and tolerability: Columbia-Suicide Severity Rating Scale (C-SSRS) categorization.
Measured over Up to 7 days
Safety and tolerability: Change from baseline in Brief Psychiatric Rating Scale (BPRS).
Measured over From baseline up to 7 days

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 64 Years

Ages

All

Sex

Accepted

Healthy volunteers

Inclusion Criteria: * Body mass index (BMI) in the range of 18.5 to 35 kg/m2 (inclusive) at screening * Good mental health in the opinion of the investigator. * Normal spirometry (FEV1 of \>80% of predicted and FVC of \>80% of predicted value) at screening. Exclusion Criteria: * Has known allergies or hypersensitivity or any other contraindication to mebufotenin, bufotenin, melatonin or triptans. * Has received any investigational medication, including investigational vaccines, in the 3 months prior to baseline or is in the follow-up period of another clinical trial at the time of screening for this trial. * 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	London	—	United Kingdom

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.

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NCT06511947 on ClinicalTrials.gov →

Last updated in the registry 2024-08-07. 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 →