MLS101 Study in PMDD

The purpose of this trial is to investigate the safety and tolerability of intermittentlow‐dose MLS101 (psilocybin) 2mg, 4mg, and 8mg versus placebo in participants with PMDD.These doses are less than one third of the doses typically administered in high‐dosepsilocybin studies.The study will enroll premenopausal women, ages 18‐50 (inclusive) with an existingdiagnosis of PMDD and history of having tried at least 1 prior treatment for PMDD. Thereis an initial Screening/Preparation Period of up to 2‐5 weeks. The 16‐day TreatmentPeriod will span the luteal phase of 1 menstrual cycle. During this time, participantswill receive 6 doses of MLS101 capsules in the clinic approximately every 3 days. Afterthe Treatment Period, there is a Follow‐up Period of approximately 1 month.Participants will be monitored after receiving each dose for at least 8 hours in theclinic and must meet specified criteria before discharge. All participants will beescorted home by a companion or via concierge care service after each dosing session.