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NCT Number: NCT07540494

Pharmacokinetics and Safety of GH001 Delivered 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.

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Key information

Conditions

Healthy Adult

Age range

21 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GH Research Clinical Trial Site

Miami, Florida, 33319, United States

Location contact

GH Research Clinical Trial Site

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

5 Methoxy N,N Dimethyltryptamine

Drug

GH001 administered via inhalation

Other names: Mebufotenin, GH001, 5-MeO-DMT

GH001 Aerosol Delivery System

Device

GH001 aerosol delivery system

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

GH Research Limited Clinical Trial Enquiries

CONTACT

[email protected]

+353874503237

Sponsors and collaborators

Lead sponsor

GH Research Ireland Limited

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2026
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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