Healthy AdultPhase 1NCT07540494
Pharmacokinetics and Safety of GH001 Delivered Via a GH001 Aerosol Delivery System in Healthy Subjects
A Phase 1 study testing 5 Methoxy N,N Dimethyltryptamine and GH001 Aerosol Delivery System in people with Healthy Adult, run by GH Research Ireland Limited at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult
- What is being tested?
- 5 Methoxy N,N Dimethyltryptamine and GH001 Aerosol Delivery System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2026to 22 May 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
GH Research Clinical Trial Site
Miami, Florida, 33319
About this study
Official title: An Open-label Phase 1 Trial to Determine the Pharmacokinetics, Pharmacodynamics and Safety of GH001 Administered Via a GH001 Aerosol Delivery System in Healthy Subjects
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.
- Conditions
- Healthy Adult
- Being tested
- 5 Methoxy N,N Dimethyltryptamine, GH001 Aerosol Delivery System
- Keywords
- Mebufotenin, 5-MeO-DMT, 5-methoxy-N,N-dimethyltryptamine, GH001, Healthy volunteers, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 Methoxy N,N DimethyltryptamineDrug
Also called Mebufotenin, GH001, 5-MeO-DMT
GH001 administered via inhalation
GH001 Aerosol Delivery SystemDevice
GH001 aerosol delivery system
| Study group | Role | What they receive |
|---|---|---|
| GH001 | Experimental | A single inhaled dose of GH001 administered via a proprietary aerosol delivery device in 12 subjects Receives: Drug: 5 Methoxy N,N Dimethyltryptamine; Device: GH001 Aerosol Delivery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum PK parameters of mebufotenin - maximum observed concentration (Cmax)
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
Measured: Day 1
Serum PK parameters of mebufotenin - time of maximum observed concentration (Tmax)
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
Measured: Day 1
Serum PK parameters of mebufotenin - terminal elimination half-life (t1/2)
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
Measured: Day 1
Serum PK parameters of mebufotenin - area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUClast)
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
Measured: Day 1
Serum PK parameters of mebufotenin - area under the serum concentration-time curve extrapolated to infinity (AUCinf)
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
Measured: Day 1
Serum PK parameters of mebufotenin - Partial area under the curve between t1 and t2 (AUCt1-t2)
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
Measured: Day 1
Serum PK parameters of mebufotenin - terminal elimination rate constant (λz)
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
Measured: Day 1
Serum PK parameters of mebufotenin - apparent total body clearance (CL/F)
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
Measured: Day 1
Serum PK parameters of mebufotenin - Apparent volume of distribution (up to bioavailability) following extravascular administration (Vz/F)
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
Measured: Day 1
Serum PK parameters of mebufotenin - Cmax/AUCinf
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
Measured: Day 1
Safety and tolerability: incidence of treatment-emergent adverse events
Incidence of adverse events reported in the study and coded by MedDRA.
Measured: Through trial completion, an average of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start18 Mar 2026
- Primary completion8 May 2026
- Study completion22 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- GH Research Ireland Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07540494
- Sponsor's protocol ID
- GH001-HV-109
- Status last verified
- Oct 2026
- First submitted
- 1 Apr 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Phase 1 Trial to Determine the Pharmacokinetics, Pharmacodynamics and Safety of GH001 Administered Via a GH001 Aerosol Delivery System in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07540494
- Acronym / sponsor ID
- GH001-HV-109
- Conditions
- Healthy Adult
- Keywords
- Mebufotenin, 5-MeO-DMT, 5-methoxy-N,N-dimethyltryptamine, GH001, Healthy volunteers, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- GH Research Ireland LimitedIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- 8 May 2026 (actual)
- Study completion
- 22 May 2026 (actual)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GH001 | Experimental | Drug: 5 Methoxy N,N Dimethyltryptamine, Device: GH001 Aerosol Delivery SystemA single inhaled dose of GH001 administered via a proprietary aerosol delivery device in 12 subjects |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5 Methoxy N,N DimethyltryptamineAlso: Mebufotenin, GH001, 5-MeO-DMTGH001 administered via inhalation | Drug | GH001 |
| GH001 Aerosol Delivery SystemGH001 aerosol delivery system | Device | GH001 |
Primary outcome
Serum PK parameters of mebufotenin - maximum observed concentration (Cmax)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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/AUCinf
Time frame: 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.
Safety and tolerability: incidence of treatment-emergent adverse events
Time frame: Through trial completion, an average of 3 weeks
Incidence of adverse events reported in the study and coded by MedDRA.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 5 Methoxy N,N Dimethyltryptamine and GH001 Aerosol Delivery System in people with Healthy Adult, run by GH Research Ireland Limited at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum PK parameters of mebufotenin - maximum observed concentration (Cmax) (time frame: Day 1). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.