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Not yet recruiting Phase 1 NCT07540494

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

Phase 1 – testing safety in a small group of people
Conditions: Healthy Adult

Sponsor: GH Research Ireland Limited

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Overview
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.
Who can participate
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.
Interventions
5 Methoxy N,N Dimethyltryptamine
DRUG
GH001 Aerosol Delivery System
DEVICE
Locations 1
United States (1)
GH Research Clinical Trial Site
Miami , Florida
Technical details
Status
Not yet recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
21 Years
Maximum age
64 Years
Healthy volunteers
No
Start date
01.04.2026
Completion date
01.05.2026
Registry ID
NCT07540494
Source
clinicaltrials.gov
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