The Safety and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder

Open-label single-group Phase II trial evaluating safety and tolerability of a single 25 mg oral COMP360 psilocybin dose in adults with PTSD, administered with psychological support.

Key outcomes include adverse events, vital signs, and clinician-rated PTSD severity (CAPS) with assessments at baseline and follow-up; participants must discontinue prohibited medications and meet CAPS and PCL-5 thresholds at baseline.