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.
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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)
Timeframe: Up to 6 hours
GH Research Limited Clinical Trial Enquiries
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