Atai Life Sciences' (NASDAQ:ATAI) wholly-owned subsidiary EmpathBio has received Medsafe central regulatory and the Health and Disability Ethics Committees (HDEC) approvals to begin participant enrollment in its Phase 1 trial of proprietary MDMA-based drug EMP-01, designed to treat PTSD and other mental health conditions.
The randomized, double-blind, placebo-controlled study intends to evaluate the safety and tolerability of single-ascending oral doses of EMP-01 in 32 healthy adult participants, as well as to assess the usability and acceptability of the IDEA-1 app in delivering “set and setting” content to participants in preparation for the drug administration.
