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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
GH001 administered via inhalation
GH001 aerosol delivery system
GH Research Clinical Trial Site
Miami, Florida, United States
Serum PK parameters of mebufotenin - maximum observed concentration (Cmax)
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
Time frame: Day 1
Serum PK parameters of mebufotenin - time of maximum observed concentration (Tmax)
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
Time frame: Day 1
Serum PK parameters of mebufotenin - terminal elimination half-life (t1/2)
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
Time frame: Day 1
Serum PK parameters of mebufotenin - area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUClast)
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
Time frame: Day 1
Serum PK parameters of mebufotenin - area under the serum concentration-time curve extrapolated to infinity (AUCinf)
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
Time frame: Day 1
Serum PK parameters of mebufotenin - Partial area under the curve between t1 and t2 (AUCt1-t2)
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
Time frame: Day 1
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Serum PK parameters of mebufotenin - terminal elimination rate constant (λz)
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
Time frame: Day 1
Serum PK parameters of mebufotenin - apparent total body clearance (CL/F)
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
Time frame: Day 1
Serum PK parameters of mebufotenin - Apparent volume of distribution (up to bioavailability) following extravascular administration (Vz/F)
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
Time frame: Day 1
Serum PK parameters of mebufotenin - Cmax/AUCinf
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
Time frame: Day 1
Safety and tolerability: incidence of treatment-emergent adverse events
Incidence of adverse events reported in the study and coded by MedDRA.
Time frame: Through trial completion, an average of 3 weeks