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

Starting soon · Phase 1

Conditions studied: Healthy Adult

In brief

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 facts

Study ID

NCT07540494

Run by

GH Research Ireland Limited

People needed

12

Starts

2026-04-01

Expected to finish

2026-05-01

Last updated by the study team

2026-04-20

Who can join

Age: 21 and older, up to 64. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• GH Research Clinical Trial Site — Miami, Florida, United States

Full record on ClinicalTrials.gov

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