A phase I, open-label, randomised-sequence, two-way crossover study to assess the relative oral bioavailability of 25 mg and 5 mg strength capsules of COMP360 in healthy volunteers

Randomised-sequence, two-period crossover in healthy volunteers to assess relative oral bioavailability of COMP360 25 mg delivered as 1×25 mg versus 5×5 mg capsules; each participant receives both regimens in separate dosing periods.

Primary endpoints are plasma PK parameters for psilocin (Cmax, AUC0-24h, AUC0-inf); secondary endpoints include additional PK metrics, safety assessments (AEs, vitals, ECG, labs), and psychiatric measures including C-SSRS and BPRS+.