Not Yet RecruitingPhase 1

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

United States12 participantsStarted 2026-04

Plain-language 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.

Who can participate

Age range

21 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Day 1

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

Timeframe: Day 1

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

Timeframe: Day 1

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

Timeframe: Day 1

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

Timeframe: Day 1

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

Timeframe: Day 1

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

Trial details

NCT IDNCT07540494

SponsorGH Research Ireland Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05

Contact for this trial

GH Research Limited Clinical Trial Enquiries

+353874503237 clinicaltrials@ghres.com

View on ClinicalTrials.gov More Healthy Adult trials

Who can participate

Age range

21 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Day 1

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

Timeframe: Day 1

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

Timeframe: Day 1

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

Timeframe: Day 1

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

Timeframe: Day 1

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

Timeframe: Day 1

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