Clinical TrialHealthy Volunteers5-MeO-DMT5-MeO-DMT5-MeO-DMT5-MeO-DMT5-MeO-DMTCompleted

Safety of GH001 in Healthy Volunteers

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.

Target Enrollment
22 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

Phase I, non-randomised sequential study in healthy volunteers evaluating single ascending doses (Part A) and an individualized dosing regimen (Part B) of inhaled GH001 (5‑MeO‑DMT).

Primary outcomes focus on safety and dose-related psychoactive effects; 22 participants enrolled across four ascending-dose groups and one individualized-dosing group.

Study Arms & Interventions

Dose A

experimental

Part A dose group A (single ascending dose).

Interventions

  • 5-MeO-DMT
    via Inhalation• single dose

    GH001 (5‑MeO‑DMT) administered via inhalation — Part A single ascending dose group A.

Dose B

experimental

Part A dose group B (single ascending dose).

Interventions

  • 5-MeO-DMT
    via Inhalation• single dose

    GH001 (5‑MeO‑DMT) administered via inhalation — Part A single ascending dose group B.

Dose C

experimental

Part A dose group C (single ascending dose).

Interventions

  • 5-MeO-DMT
    via Inhalation• single dose

    GH001 (5‑MeO‑DMT) administered via inhalation — Part A single ascending dose group C.

Dose D

experimental

Part A dose group D (single ascending dose).

Interventions

  • 5-MeO-DMT
    via Inhalation• single dose

    GH001 (5‑MeO‑DMT) administered via inhalation — Part A single ascending dose group D.

Individualized

experimental

Part B individualized dosing regimen.

Interventions

  • 5-MeO-DMT
    via Inhalation• individualized dosing

    GH001 (5‑MeO‑DMT; individualized dosing) administered via inhalation — Part B.

Participants

Ages
18 – 45
Sexes
Male & Female

Inclusion Criteria

  • 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

  • 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.

Study Details

Locations

Clinical Trial Site — Maastricht, Netherlands

Your Library