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.
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.
Intramuscular 5-MeO-DMT single-ascending (0.5–13 mg) and multiple-ascending dose cohorts (2.5 mg followed by 4.5/7/10.5 mg, 3 h apart). Randomized 5:1 active:placebo per cohort.
Cohort 1 single-dose 0.5 mg.
Cohort 2 single-dose 2.5 mg.
Cohort 3 single-dose 4.5 mg.
Cohort 4 single-dose 7 mg.
Cohort 5 single-dose 10 mg.
Cohort 6 single-dose 13 mg.
2.5 mg then 4.5 mg, 3 h apart (multiple-dose cohorts).
2.5 mg then 7 mg, 3 h apart.
2.5 mg then 10.5 mg, 3 h apart.
Saline placebo administered IM, volume matched; randomized 1 per 6 in each cohort.
0.9% sodium chloride injection; administered single or as matched two-dose schedule per cohort.