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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

This study will include separate single- and multiple-dose parts.

Part 1 (Single-Dose Part):

An open-label, non-randomized, parallel design where subjects will be assigned to receive single doses of GH001 delivered via a proprietary aerosol delivery device on a single day in three consecutive cohorts (Cohorts A, B, and C) with eight subjects per cohort. Up to two additional cohorts (Cohorts D and E) may be added before Part 2 is initiated.

Part 2 (Multiple-Dose Part):

An open-label, non-randomized design where up to three escalating doses of GH001 will be administered to subjects via a proprietary aerosol delivery device on a single day in one cohort of 12 subjects (Cohort F).

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Intervention Type DRUG

GH001 administered via inhalation

Interventions

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5 Methoxy N,N Dimethyltryptamine

GH001 administered via inhalation

Intervention Type DRUG

Other Intervention Names

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Mebufotenin, 5-MeO-DMT, GH001

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes