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Not yet recruitingPhase 1

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

NCT07540494 · GH Research Ireland Limited

Closed to entry
Status
Not accepting participants
Phase 1
Phase
12
Target enrolment
1
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Serum PK parameters of mebufotenin - maximum observed concentration (Cmax)

    Measured over Day 1

  • Serum PK parameters of mebufotenin - time of maximum observed concentration (Tmax)

    Measured over Day 1

  • Serum PK parameters of mebufotenin - terminal elimination half-life (t1/2)

    Measured over Day 1

  • Serum PK parameters of mebufotenin - area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUClast)

    Measured over Day 1

  • Serum PK parameters of mebufotenin - area under the serum concentration-time curve extrapolated to infinity (AUCinf)

    Measured over Day 1

  • Serum PK parameters of mebufotenin - Partial area under the curve between t1 and t2 (AUCt1-t2)

    Measured over Day 1

  • Serum PK parameters of mebufotenin - terminal elimination rate constant (λz)

    Measured over Day 1

  • Serum PK parameters of mebufotenin - apparent total body clearance (CL/F)

    Measured over Day 1

  • Serum PK parameters of mebufotenin - Apparent volume of distribution (up to bioavailability) following extravascular administration (Vz/F)

    Measured over Day 1

  • Serum PK parameters of mebufotenin - Cmax/AUCinf

    Measured over Day 1

  • Safety and tolerability: incidence of treatment-emergent adverse events

    Measured over Through trial completion, an average of 3 weeks

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

21 Years to 64 Years
Ages
All
Sex
Accepted
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 90 days 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.

Where

1 study site

FacilityCityRegionCountry
GH Research Clinical Trial SiteMiamiFloridaUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT07540494 on ClinicalTrials.gov →

Last updated in the registry 2026-04-20. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Recruiting in

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