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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
Where Is This Study? (1 UK site)
GH Research Clinical Trial Site
London, United Kingdom
