Safety of GH001 in Healthy Volunteers

DMT

Brief Summary

The aim of the study is to investigate the safety of GH001 (containing 5-methoxy-dimethyltryptamine; 5-MeO-DMT), and its dose-related psychoactive effects in healthy volunteers. The study will evaluate single, ascending doses of GH001 in Part A and an individualized dosing regimen of GH001 in Part B.

Intervention / Treatment

Part A: Dose ranging in four dose groups Part B: One group with individualized dosing
  • 5 Methoxy N,N Dimethyltryptamine (DRUG)
    GH001 administered via inhalation

Condition or Disease

  • Healthy Volunteers

Phase

  • Phase 1

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 45 Years
    Enrollment: 22 (ACTUAL)
    Funded by: Industry
    Allocation: Non-Randomized
    Primary Purpose: Treatment

    Masking

    Clinical Trial Dates

    Start date: Mar 13, 2019 ACTUAL
    Primary Completion: Oct 04, 2019 ACTUAL
    Completion Date: Oct 04, 2019 ACTUAL
    Study First Posted: Nov 23, 2020 ACTUAL
    Last Updated: Aug 11, 2023

    Sponsors / Collaborators

    Lead Sponsor: GH Research
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Maastricht, Limburg, Netherlands

    Participant Groups

    • No description provided

    • No description provided

    • No description provided

    • No description provided

    • No description provided

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 45
    Age Groups: Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * Subject has a body mass index (BMI) in the range of 18.5 and 27.0 kg/m2 (inclusive);
    * Subject is in good general health in the opinion of the medical supervisor;
    * Subject is in good mental health in the opinion of the (clinical) psychologist as determined by the intake interview;

    Exclusion Criteria:

    * Has known allergies or hypersensitivity or any other contraindication to 5-MeO-DMT;
    * Has received any investigational medication within the last 1 month.
    * Has a medically significant condition, which renders the subject unsuitable for the study.

    Primary Outcomes

    • The safety and tolerability of GH001 is judged by the Study Safety Group based on a combined analysis of reported adverse events, clinical observation, and safety laboratory analyses.

    • Visual Analogue Scale scored from 0-100

    More Details

    NCT Number: NCT04640831
    Other IDs: GH001-HV-101
    Study URL: https://clinicaltrials.gov/study/NCT04640831
    Last updated: Oct 02, 2023