Open-label Phase I single-group study (n=8) comparing oral (25 mg) and IV (5 mg) psilocybin in healthy adults to assess bioavailability, subjective effects and safety.
This study compares a single oral 25 mg dose and a single 5 mg intravenous infusion of psilocybin in healthy, screened adults to evaluate pharmacokinetic differences, psychedelic subjective effects and safety.
Each participant receives both routes in separate visits with psychological support; IV dosing is expected to give more consistent blood levels than oral dosing.
Participants are involved for approximately 12 weeks including screening, dosing visits and follow-up assessments.
Crossover single-group: each participant receives one oral (25 mg) session and one IV (5 mg) session with psychological support.
25 mg capsule, single oral session
5 mg intravenous infusion, single session