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

Part of paid clinical trials in Miami, Florida.

Sponsor
GH Research Ireland Limited
Study ID
NCT07540494
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Healthy Adult

Eligibility Criteria

Sex
ALL
Age
21 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • 5 Methoxy N,N Dimethyltryptamine — DRUG
    GH001 administered via inhalation
  • GH001 Aerosol Delivery System — DEVICE
    GH001 aerosol delivery system

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Apr 2026
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: GH001
    A single inhaled dose of GH001 administered via a proprietary aerosol delivery device in 12 subjects

Primary Outcome Measure

Serum PK parameters of mebufotenin - maximum observed concentration (Cmax) [ Time Frame: Day 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
GH Research Clinical Trial SiteMiamiFlorida33319
GH Research Clinical Trial Site

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By research site
GH Research Clinical Trial Site· Miami, FL

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