A Study of a Psilocybin Analog (CYB003) in Healthy Participants With and Without Major Depressive Disorder
This Phase I/II randomised, double-blind, placebo-controlled trial (n=57) studied the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending oral doses of CYB003, a synthetic psilocybin analogue, in healthy participants and those with major depressive disorder (MDD).
Details
Randomised, quadruple-blind, parallel Phase I/II study (n=57) evaluating ascending oral doses of CYB003 in healthy volunteers and participants with MDD; key outcomes include safety, tolerability, PK and PD.
MDD participants received EMBARK manualised psychotherapy throughout; healthy volunteers received manualised psychological support. Medicine sessions occurred 1–3 weeks apart depending on cohort, with some cohorts receiving three sessions to assess bioavailability and food effects.
Safety assessments included vital signs, labs, ECG, and psychiatric evaluation; exclusion criteria include clinically significant suicidality, MAOI use, pregnancy, relevant medical conditions, and recent investigational drug exposure.