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

GH Research

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: 5 Methoxy N,N Dimethyltryptamine

Study type: Interventional

Funder types: Industry

Identifiers

NCT06511947

IRAS Number (Other Identifier)

GH001-HV-106-2

Details and patient eligibility

About

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.

Enrollment: 52 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 6 patient groups

Part 1, Cohort A

Experimental group

Description:

A single dose inhaled dose of 6 mg GH001 administered via a proprietary aerosol delivery device in eight subjects.

Treatment:

Drug: 5 Methoxy N,N Dimethyltryptamine

Part 1, Cohort B

Experimental group

Description:

A single dose inhaled dose of 12 mg GH001 administered via a proprietary aerosol delivery device in eight subjects.

Treatment:

Drug: 5 Methoxy N,N Dimethyltryptamine

Part 1, Cohort C

Experimental group

Description:

A single dose inhaled dose of 18 mg GH001 administered via a proprietary aerosol delivery device in eight subjects.

Treatment:

Drug: 5 Methoxy N,N Dimethyltryptamine

Part 1, Cohort D (optional)

Experimental group

Description:

A single inhaled intermediate dose of 8, 9, 10, 14, 15, or 16 mg GH001 administered via a proprietary aerosol delivery device in eight subjects (optional cohort dependent on study safety group \[SSG\] review of PK, PD and safety data from Cohorts A, B, and C).

Treatment:

Drug: 5 Methoxy N,N Dimethyltryptamine

Part 1, Cohort E (optional)

Experimental group

Description:

A single inhaled intermediate dose of 8, 9, 10, 14, 15, or 16 mg GH001 administered via a proprietary aerosol delivery device in eight subjects (optional cohort dependent on SSG review of PK, PD and safety data from Cohorts A, B, and C).

Treatment:

Drug: 5 Methoxy N,N Dimethyltryptamine

Part 2, Cohort F

Experimental group

Description:

Up to three escalating inhaled doses of GH001 (doses as determined by Part 1, maximum single inhaled dose of 18 mg) administered via a proprietary aerosol delivery device in 12 subjects.

Treatment:

Drug: 5 Methoxy N,N Dimethyltryptamine