Pharmacokinetics, Safety, and Tolerability of Intramuscular 5-MeO-DMT in Healthy Volunteers
This double-blind, placebo-controlled trial (n=54) will administer 5-MeO-DMT intramuscularly in varying doses (single 0.5–13 mg and multiple-dose combinations) in healthy adults to assess pharmacokinetics, safety, and tolerability.
Details
Phase I, randomized, triple-blind, placebo-controlled, sequential-group study in 54 healthy adults assessing single-ascending and multiple-ascending IM doses of 5-MeO-DMT (single doses 0.5–13 mg; multiple-dose schedules include 2.5 mg followed by 4.5, 7, or 10.5 mg with a 3-hour interval).
Primary objective is characterisation of pharmacokinetics, safety, and tolerability; secondary assessments include adverse events, vitals, ECGs, and laboratory evaluations across acute and follow-up visits.
Randomization is 5:1 active to placebo per cohort with separate single- and multiple-dose parts and sequential dose escalation based on safety review.