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

April 14, 2026 updated by: GH Research Ireland Limited

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33319
        • GH Research Clinical Trial Site
        • Contact:
          • GH Research Clinical Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GH001
A single inhaled dose of GH001 administered via a proprietary aerosol delivery device in 12 subjects
Drug: 5 Methoxy N,N Dimethyltryptamine
GH001 administered via inhalation
Other Names:
  • GH001
  • 5-MeO-DMT
  • Mebufotenin
Device: GH001 Aerosol Delivery System
GH001 aerosol delivery system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1
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.
Day 1
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.
Day 1
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.
Day 1
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.
Day 1
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.
Day 1
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.
Day 1
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.
Day 1
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.
Day 1
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.
Day 1
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.
Through trial completion, an average of 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GH Research Ireland Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

April 1, 2026

First Submitted That Met QC Criteria

April 14, 2026

First Posted (Actual)

April 20, 2026

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GH001-HV-109

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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