Clinical Trial

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

Recruiting Phase 1
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Record status
This record was last updated August 7, 2024 (before its estimated February 2025 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-07-15.
Status change: Not Yet Recruiting → Recruiting 2024-08-06
Trial Details
NCT Number NCT06511947
Lead Sponsor GH Research Ireland Limited
Conditions Healthy Volunteers
Enrollment 52 participants
Start Date 2024-08-01
Primary Completion 2025-02 (estimated)
Study Completion 2025-02 (estimated)
Updated on ClinicalTrials.gov 2024-08-07