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.
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.
Single IV bolus GH002 in cohorts A–G (randomised 6 active : 2 placebo per cohort).
GH002 (5‑MeO‑DMT) IV bolus; dose escalation by cohort (A→G) per protocol.
Placebo IV bolus administered in single-dose cohorts (Cohorts A–G).
Open-label, non-randomized cohort J with up to 3 IV bolus doses within a single day.
Up to 3 individualized IV bolus doses given on a single day; doses determined after unblinded review.