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.
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.
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.
Single group
5 Methoxy N,N Dimethyltryptamine
DrugGH001 administered via inhalation
GH001 Aerosol Delivery System
DeviceGH001 aerosol delivery system
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.
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.
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.
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.
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