A study carried out on healthy volunteers to understand how COMP360 can be taken in a safe and well-tolerated way
Phase I, randomised double‑blind placebo‑controlled single‑dose PK study (n=44) with an integrated open‑label food‑effect crossover (25 mg) assessing safety, tolerability, PK and QTcF of COMP360 (psilocybin) in healthy volunteers.
Details
This interventional Phase I trial enrolled 44 healthy volunteers to characterise the pharmacokinetics and safety of oral COMP360 (psilocybin), using single‑dose PK cohorts (1, 10, 25, 50 mg; 6 active:2 placebo per cohort) and a separate food‑effect crossover (25 mg fasted vs fed).
Primary endpoints include adverse events, 12‑lead ECG/QTcF monitoring, vital signs and clinical laboratories; secondary endpoints include plasma concentrations of psilocybin, psilocin and metabolites and PK parameters.
Dosing was observed in a clinical research unit with overnight stay for 24‑hour monitoring; suicidality assessments (C‑SSRS) and post‑dose safety checks were performed prior to discharge.