A Phase 1 Randomized, First-in-Human, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-Ascending Doses of EMP-01 in Healthy Adult Volunteers
This randomised, double-blind, placebo-controlled Phase I trial (n=32) assesses safety, tolerability, PK and PD of single-ascending oral doses of EMP-01 (ar-MDMA) in healthy adults across four cohorts (75–225 mg).
Details
Randomised, double-blind, placebo-controlled, single-ascending dose study in healthy volunteers across four cohorts (8 per cohort). Doses: 75 mg, 125 mg, 175 mg and 225 mg; cohort 2 includes two treatment periods (fasted and fed) with the same investigational product.
Safety assessments include AEs/SAEs, vitals (BP, HR, RR, temperature), ECG and clinical labs. Intensive PK sampling scheduled up to 30 hours postdose (multiple timepoints on Day 1 and Day 2; additional sampling for Cohort 2 Day 9/10). SMG sentinel review after initial two participants per cohort, with progression decisions after safety review.