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GH001 Aerosol Delivery System in Healthy Adults

This study is testing a new way to give a drug called GH001 using a special inhaler (aerosol delivery system). We want to understand how your body handles GH001 (this is called pharmacokinetics or PK) and if it's safe and well-tolerated after a single dose. We'll be looking at things like how much GH001 is in your blood and how long it stays there. You might be able to join if you are a healthy adult between 21 and 64 years old, have a healthy body weight (BMI between 18.5 and 35), good mental health, and normal lung function. The study aims to enroll 12 people. The current recruitment status is unclear.

Study design
This is an interventional study, but the phase is not specified. It plans to enroll 12 healthy adult participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary measurements for the drug in your blood are taken on Day 1.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07540494

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

Not Yet Recruiting
PHASE1Ages 21–64InterventionalTreatment
GH Research Ireland Limited
~12 participants
Updated 2026-04-20 on ClinicalTrials.gov
What's tested:5 Methoxy N,N DimethyltryptamineGH001 Aerosol Delivery System

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Serum PK parameters of mebufotenin - maximum observed concentration (Cmax)
Measured over Day 1
+10 more outcomes measured

Conditions

Healthy Adult

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Healthy Volunteer

Where it's being run

1 sites across 1 states
Florida1

Who to contact

GH Research Limited Clinical Trial Enquiries
[email protected]
+353874503237
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Serum PK parameters of mebufotenin - maximum observed concentration (Cmax)Day 1

    For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.

  • Serum PK parameters of mebufotenin - time of maximum observed concentration (Tmax)Day 1

    For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.

  • Serum PK parameters of mebufotenin - terminal elimination half-life (t1/2)Day 1

    For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.

  • Serum PK parameters of mebufotenin - area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUClast)Day 1

    For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.

  • Serum PK parameters of mebufotenin - area under the serum concentration-time curve extrapolated to infinity (AUCinf)Day 1

    For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.

  • Serum PK parameters of mebufotenin - Partial area under the curve between t1 and t2 (AUCt1-t2)Day 1

    For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.

  • Serum PK parameters of mebufotenin - terminal elimination rate constant (λz)Day 1

    For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.

  • Serum PK parameters of mebufotenin - apparent total body clearance (CL/F)Day 1

    For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.

  • Serum PK parameters of mebufotenin - Apparent volume of distribution (up to bioavailability) following extravascular administration (Vz/F)Day 1

    For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.

  • Serum PK parameters of mebufotenin - Cmax/AUCinfDay 1

    For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.

  • Safety and tolerability: incidence of treatment-emergent adverse eventsThrough trial completion, an average of 3 weeks

    Incidence of adverse events reported in the study and coded by MedDRA.