Not Yet RecruitingPhase 1DMT

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

Sponsored by GH Research Ireland Limited

NCT ID
NCT07540494
Target Enrollment
12 participants
Start Date
2026-04
Est. Completion
2026-05

About This Study

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.

Conditions Studied

Healthy Adult

Interventions

  • 5 Methoxy N,N Dimethyltryptamine
  • GH001 Aerosol Delivery System

Eligibility

Age:21 Years - 64 Years
Healthy Volunteers:Yes
View full eligibility 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 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.

Study Locations (1)

GH Research Clinical Trial Site
Miami, Florida, United States

Interested in this trial?

Contact the study team to learn more about eligibility and enrollment.

GH Research Limited Clinical Trial Enquiries
CONTACT
+353874503237clinicaltrials@ghres.com
View on ClinicalTrials.gov
Data Source
ClinicalTrials.gov

Last updated from source