RecruitingPhase 1DMT

Pharmacokinetics of GH001 Delivered Via a Proprietary Aerosol Delivery Device in Healthy Subjects

NCT ID

NCT06511947

Target Enrollment

52 participants

Start Date

2024-08-01

Est. Completion

2025-02

About This Study

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.

Conditions Studied

Healthy Volunteers

Interventions

•5 Methoxy N,N Dimethyltryptamine

Eligibility

Age:18 Years - 64 Years

Healthy Volunteers:Yes

View full eligibility criteria

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 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.

Study Locations (1)

GH Research Clinical Trial Site