Status:
RECRUITING
Pharmacokinetics of GH001 Delivered Via a Proprietary Aerosol Delivery Device in Healthy Subjects
Lead Sponsor:
GH Research Ireland Limited
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT06511947
Start Date
August 1 2024
End Date
February 1 2025
Last Update
August 7 2024
Active Locations (1)
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1
GH Research Clinical Trial Site
London, United Kingdom