Clinical TrialHealthy Volunteers5-MeO-DMTPlacebo5-MeO-DMTPlacebo5-MeO-DMTPlacebo5-MeO-DMT5-MeO-DMTCompleted

Pharmacokinetics of GH001 in Healthy Volunteers

Randomized, double-blind, placebo-controlled single-dose and open-label multiple-dose Phase I study in healthy volunteers (n=46) assessing inhaled GH001 (5‑MeO‑DMT) at 6, 12 and 18 mg for pharmacokinetics, safety and psychoactive effects.

Target Enrollment
46 participants
Study Type
Phase I interventional
Design
Randomized, triple Blind

Detailed Description

This Phase I study in healthy volunteers used a randomized, double-blind, placebo-controlled parallel design for single inhaled doses (6, 12, 18 mg; groups A–C) and an open-label, non-randomized multiple-dose part with up to three inhaled doses in one day (6→12→18 mg; groups D–E) to characterise serum pharmacokinetics of 5‑MeO‑DMT (GH001) and its metabolite bufotenine.

Secondary assessments included safety and tolerability, acute psychoactive effects and cognitive measures; masking was triple (participant, investigator, outcomes assessor) for the single-dose, placebo-controlled part.

Study Protocol

Preparation

sessions

Dosing

3 sessions

Integration

sessions

Study Arms & Interventions

GH001 6 mg

experimental

Single inhaled dose 6 mg or placebo (randomized, 8 active/2 placebo per group).

Interventions

  • 5-MeO-DMT6 mg
    via Inhalation• single dose• 1 doses total
  • Placebo
    via Inhalation• single dose

    GH001 placebo inhalation

GH001 12 mg

experimental

Single inhaled dose 12 mg or placebo (randomized, 8 active/2 placebo per group).

Interventions

  • 5-MeO-DMT12 mg
    via Inhalation• single dose• 1 doses total
  • Placebo
    via Inhalation• single dose

    GH001 placebo inhalation

GH001 18 mg

experimental

Single inhaled dose 18 mg or placebo (randomized, 8 active/2 placebo per group).

Interventions

  • 5-MeO-DMT18 mg
    via Inhalation• single dose• 1 doses total
  • Placebo
    via Inhalation• single dose

    GH001 placebo inhalation

GH001 6→12→18 (1h)

experimental

Open-label, non-randomized up to 3 inhaled doses within one day with 1-hour interval (6→12→18 mg).

Interventions

  • 5-MeO-DMT6 - 18 mg
    via Inhalation• multiple doses in one day• 3 doses total

    1-hour interval; escalation 6→12→18 mg

GH001 6→12→18 (2h)

experimental

Open-label, non-randomized up to 3 inhaled doses within one day with 2-hour interval (6→12→18 mg).

Interventions

  • 5-MeO-DMT6 - 18 mg
    via Inhalation• multiple doses in one day• 3 doses total

    2-hour interval; escalation 6→12→18 mg

Participants

Ages
18 – 64
Sexes
Male & Female

Inclusion Criteria

  • Subject has a body mass index (BMI) in the range of 18.5 and 35.0 kg/m2 (inclusive);
  • Subject is in good physical health in the opinion of the principal investigator (PI);
  • Subject is in good mental health in the opinion of the PI and clinical psychologist;

Exclusion Criteria

  • Has known allergies or hypersensitivity or any other contraindication to 5-MeO-DMT;
  • Has received any investigational medication within the last 4 weeks;
  • Has a medical condition, which renders the subject unsuitable for the study.

Study Details

Locations

GH Research Clinical Trial Site — Groningen, Netherlands

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