Xylo Bio has dosed the first participants in an Australian Phase 1 study of XYL-1001, a non-hallucinogenic selective 5-HT2A agonist for major depressive disorder.

The randomised, double-blind, placebo-controlled trial will assess XYL-1001’s safety, tolerability, pharmacokinetics and pharmacodynamic activity in healthy volunteers across single and multiple ascending dose cohorts. Translational biomarkers will support development decisions. XYL-1001 is investigational and has not been approved by any regulatory authority.