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

NCT07540494 | Not Yet Recruiting Phase 1 FDA Drug FDA Device

• 1 other identifier: GH001-HV-109
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Adult

Keywords

Mebufotenin; 5-MeO-DMT; 5-methoxy-N,N-dimethyltryptamine; GH001; Healthy volunteers; Pharmacokinetics

Outcome Measures

Primary Outcomes (11)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Day 1

• Safety and tolerability: incidence of treatment-emergent adverse events

  Incidence of adverse events reported in the study and coded by MedDRA.

  Through trial completion, an average of 3 weeks

Study Arms (1)

GH001

EXPERIMENTAL

A single inhaled dose of GH001 administered via a proprietary aerosol delivery device in 12 subjects

Drug: 5 Methoxy N,N Dimethyltryptamine; Device: GH001 Aerosol Delivery System

Interventions

GH001 Aerosol Delivery System DEVICE

GH001 aerosol delivery system

GH001

5 Methoxy N,N Dimethyltryptamine DRUG

GH001 administered via inhalation

Also known as: Mebufotenin, GH001, 5-MeO-DMT

GH001

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• GH Research Ireland Limited: lead

Study Sites (1)

GH Research Clinical Trial Site

Miami, Florida, 33319, United States

Location

MeSH Terms

Interventions

Methoxydimethyltryptamines

Intervention Hierarchy (Ancestors)

N,N-Dimethyltryptamine; Tryptamines; Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Bufotenin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Serotonin

Central Study Contacts

GH Research Limited Clinical Trial Enquiries

CONTACT

+353874503237; clinicaltrials@ghres.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 20, 2026
• Study Start: April 1, 2026
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)