Examining the effects of GH001 delivered through an aerosol device in healthy individuals
An Open-label Phase 1 Trial to Determine the Pharmacokinetics, Pharmacodynamics, and Safety of GH001 Administered Via a Proprietary Aerosol Delivery Device in Healthy Subjects
This study is testing a new aerosol treatment called GH001 to see how it affects healthy people and if it has any impact on their thinking and safety.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | GH Research Ireland Limited Industry-sponsored |
| Locations | 1 site (London) |
| Trial ID | NCT06511947 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate the pharmacokinetics and safety of GH001, a compound containing 5-MeO-DMT, when administered via a proprietary aerosol delivery device to healthy volunteers. Participants will receive a single dose and undergo an individualized dosing regimen to assess the drug's pharmacokinetic profile and its psychoactive effects. The study will also investigate the impact of GH001 on cognitive performance and the time taken for drug concentration to decrease significantly in the body. The trial is designed to ensure participant safety and tolerability throughout the process.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults with a BMI between 18.5 and 35 kg/m2 and good mental health.
Not a fit: Patients with known allergies to mebufotenin or related compounds, or those with significant health conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the safe administration and effects of GH001, potentially paving the way for therapeutic applications.
How similar studies have performed: While the specific approach of using an aerosol device for GH001 is novel, similar studies on psychoactive compounds have shown varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion 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 allergies or hypersensitivity or any other contraindication to mebufotenin, bufotenin, melatonin or triptans. * Has received any investigational medication, including investigational vaccines, in the 3 months 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 this trial is running
London
- GH Research Clinical Trial Site — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: GH Research Limited Clinical Trial Enquiries
- Email: clinicaltrials@ghres.com
- Phone: +353 87 450 3237
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.