Pharmacokinetics and Safety of GH001 Delivered Via a GH001 Aerosol Delivery System in Healthy Subjects

This Phase I, open-label, single-group trial (n=12) will study the pharmacokinetics, pharmacodynamics and safety of GH001 in healthy adults after a single inhaled dose delivered via a proprietary GH001 aerosol delivery system. The main purpose is to assess the serum pharmacokinetic profile of mebufotenin and the safety and tolerability of the treatment. All participants will receive a single inhaled dose of GH001 via an aerosol device. The study will measure serum mebufotenin PK parameters on Day 1, including Cmax, Tmax, terminal half-life, AUClast, AUCinf, partial area under the curve, terminal elimination rate constant, clearance, volume of distribution and Cmax/AUCinf. Safety will be assessed by the incidence of treatment-emergent adverse events through trial completion, with follow-up averaging about 3 weeks. Eligibility is limited to healthy adults aged 21 to 64 years with BMI 18.5 to 35 kg/m2 and normal spirometry.