GH001 Aerosol Treatment for Healthy Volunteers
Pharmacokinetics of GH001 Delivered Via a Proprietary Aerosol Delivery Device in Healthy Subjects
Recruiting
Phase 1
Interventional Study
Healthy Volunteers
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 64
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 52 (estimated)
- Sponsor
- GH Research Ireland Limited · Industry
Who this trial is looking for
This trial is looking for healthy individuals to test a new aerosol medication called GH001. Participants will take a single dose and some will be given personalized doses over one day to help researchers understand how the drug works and its effects on the body.
Are You a Good Fit for This Trial?
You may be able to join if
- I have a body mass index (BMI) between 18.5 and 35.
- I am in good mental health.
- I have normal lung function tests.
You may not be able to join if
- I am allergic to mebufotenin, bufotenin, melatonin, or triptans.
- I have taken any investigational medication in the last 3 months.
- I have a significant medical condition that makes me unsuitable for the trial.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
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 and a single-day individualized dosing regimen (IDR). As secondary objectives, the mebufotenin PK/ pharmacodynamic (PD) relationship, the PD profile of GH001 as evalua…
Trial Locations
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Eligibility Criteria
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 allergi…
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