A Phase 1, Open-label, Single Cohort Study to Evaluate the Safety and Pharmacokinetics (PK) of a Single Intravenous (IV) Infusion of TRP-8803 [Psilocin Besylate formulation] in Healthy Adult Participants
Phase I open-label single-cohort IV study (n=4) assessing safety and PK of a single TRP-8803 (psilocin besylate) infusion (5 mg loading over 20 min then 5 mg over 120 min) with psychedelic-assisted psychotherapy in healthy adults.
Details
This open-label Phase I study will administer a single intravenous infusion of TRP-8803 (psilocin besylate) in healthy adult participants while delivering preparatory, during-session, and integration psychotherapy by a consistent therapist dyad to evaluate safety and tolerability.
Pharmacokinetic sampling includes multiple timepoints from pre-dose through 24 hours to determine plasma concentrations and PK profile; safety monitoring includes AEs, vital signs, ECG and laboratory tests with DSMB review after first participant before dosing others.
Therapy comprises one 2-hour preparation session, the dosing session with non-directive support, and two 1-hour integration sessions (within 24 hours and at two weeks) to support meaning-making and implementation of therapeutic changes.