Health Trials

Clinical trials

2

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Condition / disease
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Status: Not yet recruiting

Pharmacokinetics and Safety of GH001 Delivered Via a GH001 Aerosol Delivery System in Healthy Subjects

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.

Participants needed: 12
Trial details
Phase: Phase 1Age: 21-64Biological sex: AllType: InterventionalSponsor: GH Research Ireland LimitedUpdated: Apr 20, 2026Locations: 1
Eligibility criteria

Body mass index (BMI) in the range of 18.5 to 35 kg/m2 (inclusive) at screening. [+2]

Has known allergies or hypersensitivity or any other contraindication to mebufot... [+2]

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Status: Recruiting

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

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.

Participants needed: 52
Trial details
Phase: Phase 1Age: 18-64Biological sex: AllType: InterventionalSponsor: GH Research Ireland LimitedUpdated: Aug 7, 2024Locations: 1
Eligibility criteria

Body mass index (BMI) in the range of 18.5 to 35 kg/m2 (inclusive) at screening [+2]

Has known allergies or hypersensitivity or any other contraindication to mebufot... [+2]

Read more