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Study stopped earlyPhase1

Pharmacokinetics of GH001 Delivered Via a Proprietary Aerosol Delivery Device in Healthy Subjects

Sponsor: GH Research Ireland Limited

NCT ID: NCT06511947

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
5 Methoxy N,N Dimethyltryptamine (drug)
How long the study runs
Study runs about 19 months (dates as stated)
About the drug or intervention
5 Methoxy N,N Dimethyltryptamine — drug: GH001 administered via inhalation
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 64 Years
Who
All
Number of participants
71
Started
2024-08-01
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for healthy volunteers
  • • Phase1 - 71 participants
  • • This is an open-label Phase 1 trial in healthy subjects designed to characterize the pharmacokinetic (PK) profile, pharmacodynamics, and safety and tolerability of GH001 (mebufotenin) delivered via the GH001 Aerosol Delivery System (ADS)

Who can take part?

  • • Ages 18 Years to 64 Years
  • • Diagnosed with healthy volunteers

Where?

  • • London - GH Research Clinical Trial Site

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

This is an open-label Phase 1 trial in healthy subjects designed to characterize the pharmacokinetic (PK) profile, pharmacodynamics, and safety and tolerability of GH001 (mebufotenin) delivered via the GH001 Aerosol Delivery System (ADS). The trial is conducted in three parts. In Part 1, subjects receive a single dose of GH001 via the ADS. In Part 2, subjects receive GH001 via both the ADS and the Volcano Medic 2 Vaporization System in a crossover design, to estimate the relative bioavailability of mebufotenin between the two delivery systems. In Part 3, subjects receive a single-day individualized dosing regimen (IDR) of GH001 via the ADS, in which up to three increasing doses are given at approximately 1-hour intervals. The primary objectives are to determine the serum PK profile of mebufotenin and its metabolites and to evaluate the safety and tolerability of GH001 across these parts. Secondary objectives include characterizing the pharmacodynamic profile, as assessed by its psychoactive effects (PsE) and effects on cognitive performance, and estimating the time for the maximum serum concentration (Cmax) to decline by 50% and 90% (tCmax/2 and tCmax/10). Part 3 of this trial was not initiated. The trial was terminated after Part 2.

Healthy Volunteers

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 64 Years
  • Who can join: All genders

What the study is looking for

  • ✓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 take part

  • ✗Has known allergies or hypersensitivity or any other safety concern to mebufotenin, bufotenin, melatonin or triptans.
  • ✗Has a current or past clinically significant condition, which renders the subject unsuitable for the trial according...
See the full 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 Is This Study? (1 UK site)

GH Research Clinical Trial Site

London, United Kingdom

Data sourced from ClinicalTrials.gov · Last verified: 2026-10