A Study Assessing Brain Activity, Safety, Tolerability, and Pharmacokinetics Following Multiple Doses of MLS101 (Psilocybin) in Healthy Volunteers

Phase I, randomised, single-blind parallel study in healthy volunteers using multiple low oral doses of MLS101 (psilocybin) to assess CNS activity with fMRI alongside safety, tolerability and PK.

Outcomes include translational fMRI measures of brain response to priming and repeat low doses, cognitive and perceptual scales, and standard safety assessments (vitals, ECG, labs). Dosing schedule is multiple low-dose capsules (MLS101) versus matching placebo per protocol.