A Phase 1, Open-label, Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of a Single Intravenous Infusion of TRP-8803 (Psilocin) in Healthy Adult Participants
Phase I, open-label, non-randomised dose-escalation study (n=9) assessing safety and PK of a single 140-minute IV infusion of TRP-8803 (psilocin; 7.5, 14, or 20.5 mg) in healthy adults.
Details
Open-label, three-cohort ascending-dose study in healthy volunteers (3 participants per cohort) testing a single IV infusion of TRP-8803 with a 20-minute loading dose followed by a 120-minute maintenance infusion; SRC reviews PK and safety before escalation.
Participants remain onsite overnight for safety observation and PK sampling; PK timepoints include predose and 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 18 and 24 hours post-start of infusion with analyses of Cmax, Tmax, t1/2, AUC0-8, AUC0-24 and AUC0-t; safety assessed via AEs/SAEs, vitals, ECG, labs, suicidality assessments and Persistent Effects Questionnaire.