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

An Open-label Phase 1 Trial to Determine the Pharmacokinetics, Pharmacodynamics and Safety of GH001 Administered Via a GH001 Aerosol Delivery System in Healthy Subjects

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.

Inclusion Criteria:

• Body mass index (BMI) in the range of 18.5 to 35 kg/m2 (inclusive) at screening.
• Good mental health in the opinion of the investigator.
• Normal spirometry (FEV1 of >80% of predicted and FVC of >80% of predicted value) at screening.

Exclusion Criteria:

• Has known allergies or hypersensitivity or any other contraindication to mebufotenin, bufotenin, melatonin or triptans.
• Has received any investigational medication, including investigational vaccines, in the 90 days prior to baseline or is in the follow-up period of another clinical trial at the time of screening for this trial.
• Has a current or past clinically significant condition, which renders the subject unsuitable for the trial according to the investigator's judgement.