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.
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Serum PK parameters of mebufotenin - maximum observed concentration (Cmax)
Timeframe: Day 1
Serum PK parameters of mebufotenin - time of maximum observed concentration (Tmax)
Timeframe: Day 1
Serum PK parameters of mebufotenin - terminal elimination half-life (t1/2)
Timeframe: Day 1
Serum PK parameters of mebufotenin - area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUClast)
Timeframe: Day 1
Serum PK parameters of mebufotenin - area under the serum concentration-time curve extrapolated to infinity (AUCinf)
Timeframe: Day 1
Serum PK parameters of mebufotenin - Partial area under the curve between t1 and t2 (AUCt1-t2)
Timeframe: Day 1
Serum PK parameters of mebufotenin - terminal elimination rate constant (λz)
Timeframe: Day 1
Serum PK parameters of mebufotenin - apparent total body clearance (CL/F)
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Timeframe: Day 1
Serum PK parameters of mebufotenin - Apparent volume of distribution (up to bioavailability) following extravascular administration (Vz/F)
Timeframe: Day 1
Serum PK parameters of mebufotenin - Cmax/AUCinf
Timeframe: Day 1
Safety and tolerability: incidence of treatment-emergent adverse events
Timeframe: Through trial completion, an average of 3 weeks