Clinical TrialHealthy Volunteers5-MeO-DMTPlacebo5-MeO-DMTCompleted

Safety and Pharmacokinetics of GH002 in Healthy Volunteers

Double-blind, placebo-controlled, randomised single-dose cohorts (n=64 across cohorts A–G) and an open-label multiple-dose cohort (J) investigating safety and serum pharmacokinetics of IV GH002 (5‑MeO‑DMT) in healthy volunteers.

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

Detailed Description

This study evaluates safety and serum pharmacokinetics of GH002 (5‑MeO‑DMT) in healthy volunteers using a randomized, double‑blind, placebo‑controlled single‑dose escalation (cohorts A–G) and an open‑label, non‑randomized multiple‑dose cohort (J).

Secondary objectives include PK/PD relationships, assessment of psychoactive effects and cognitive performance, and measurement of the metabolite bufotenine.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

Single-dose GH002 (Cohorts A–G)

experimental

Single IV bolus GH002 in cohorts A–G (randomised 6 active : 2 placebo per cohort).

Interventions

  • 5-MeO-DMT
    via IV• single dose• 1 doses total

    GH002 (5‑MeO‑DMT) IV bolus; dose escalation by cohort (A→G) per protocol.

Placebo

inactive

Placebo IV bolus administered in single-dose cohorts (Cohorts A–G).

Interventions

  • Placebo
    via IV• single dose• 1 doses total

Multiple-dose GH002 (Cohort J)

experimental

Open-label, non-randomized cohort J with up to 3 IV bolus doses within a single day.

Interventions

  • 5-MeO-DMT
    via IV• multiple doses• 3 doses total

    Up to 3 individualized IV bolus doses given on a single day; doses determined after unblinded review.

Participants

Ages
18 – 45
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Has a body mass index (BMI) in the range of 18.5 and 35 kg/m2 (inclusive) at Screening.
  • Is deemed in good physical health by the investigator.
  • Is in good mental health in the opinion of the investigator and clinical psychologist

Exclusion Criteria

  • Exclusion Criteria:
  • Has known allergies or hypersensitivity or any other contra-indication to 5-MeO-DMT.
  • Has received any investigational medication, including investigational vaccines, within the 6 weeks prior to baseline.
  • Has a current or past clinically significant condition, which renders the subject unsuitable for the trial according to the Investigator's judgement.

Study Details

Locations

GH Research Clinical Trial Site — Groningen, Netherlands

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