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 and a single-day individualized dosing regimen (IDR). As secondary objectives, the mebufotenin PK/ pharmacodynamic (PD) relationship, the PD profile of GH001 as evaluated by its psychoactive effects (PsE), the impact on cognitive performance, and the TCmax/2 and TCmax/10 (time taken for Cmax to decrease by 50 and 90%, respectively) are also assessed.
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 3 months 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.
Parallel
5 Methoxy N,N Dimethyltryptamine
DrugGH001 administered via inhalation
6
Treatment groupsSee each treatment group below.
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 (AUC0-t)
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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