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.
Age range
18 Years – 64 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Serum PK parameters of mebufotenin - maximum observed concentration (Cmax)
Timeframe: Up to 6 hours
Serum PK parameters of mebufotenin - time of maximum observed concentration (Tmax)
Timeframe: Up to 6 hours
Serum PK parameters of mebufotenin - terminal elimination half-life (t1/2)
Timeframe: 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)
Timeframe: Up to 6 hours
Serum PK parameters of mebufotenin - area under the serum concentration-time curve extrapolated to infinity (AUC0-∞)
Timeframe: Up to 6 hours
Serum PK parameters of mebufotenin - terminal elimination rate constant (λz)
Timeframe: Up to 6 hours
Serum PK parameters of mebufotenin - apparent total body clearance (CL/F)
GH Research Limited Clinical Trial Enquiries
Timeframe: Up to 6 hours
Serum PK parameters of mebufotenin - apparent steady-state volume of distribution (VSS/F)
Timeframe: Up to 6 hours
Serum PK parameters of mebufotenin - Cmax/AUC0-∞
Timeframe: Up to 6 hours
Safety and tolerability: incidence of treatment-emergent adverse events
Timeframe: Up to 7 days
Safety and tolerability: clinically significant changes from baseline in electrocardiogram (ECG), vital signs, spirometry and safety laboratory assessments
Timeframe: 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
Timeframe: Postdose, up to discharge on dosing day (Day 0)
Safety and tolerability: change from baseline in Clinician Administered Dissociative States Scale (CADSS)
Timeframe: From baseline up to 7 days
Safety and tolerability: assessment of subject discharge readiness at discharge on Day 0
Timeframe: Postdose, at discharge on dosing day (Day 0)
Safety and tolerability: Columbia-Suicide Severity Rating Scale (C-SSRS) categorization.
Timeframe: Up to 7 days
Safety and tolerability: Change from baseline in Brief Psychiatric Rating Scale (BPRS).
Timeframe: From baseline up to 7 days