ELE-101 Safety & Tolerability Study in Healthy Participants and Patients With Depression
Phase I/II, randomized, triple-blind, placebo-controlled ascending-dose IV study (Part 1, HVs) and Phase IIa open-label IV study in MDD (Part 2); single IV doses of ELE-101 (psilocybin) with PK/PD and safety assessment.
Details
Part 1 is a randomised, triple-masked, single-ascending-dose IV study in healthy adults evaluating safety, tolerability, PK, PD and subjective drug intensity of ELE-101 (psilocybin) versus placebo across multiple cohorts (0.25 mg, 0.75 mg, 2.0 mg; further doses TBD).
Part 2 is an open-label Phase IIa cohort of patients with major depressive disorder receiving a single IV dose of ELE-101 to evaluate pharmacodynamic effects and safety; key outcomes include adverse events, vital signs, PK parameters and patient-reported subjective intensity.