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

This Phase I, open-label trial (n=4) will assess the safety and pharmacokinetics of a single intravenous dose of psilocin (TRP-8803; 5 mg loading over 20 minutes followed by 5 mg maintenance over 120 minutes) in healthy adults undergoing psychedelic-assisted psychotherapy.

The study is being conducted as a follow-up to a previous trial and focuses on evaluating psilocin (the active metabolite of psilocybin) delivered intravenously.

Participants will receive preparatory psychotherapy prior to dosing, followed by two integration sessions after dosing. The psychotherapy will be facilitated by a consistent pair of trained therapists, with at least one being medically qualified. This structure aims to ensure safety and support before, during, and after the psychedelic experience.

Primary outcomes include assessing safety via adverse events and physiological measures, while secondary outcomes focus on understanding the drug’s pharmacokinetics, psychological effects (e.g. mystical or emotional breakthroughs), and changes in brain activity using EEG. This trial exclusively includes healthy participants with no current or recent psychiatric diagnoses, substance use issues, or personal histories deemed incompatible with the safe use of psychedelics.

Topic Safety Healthy Subjects
Compound Psilocybin
Country Australia
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Sponsors & Collaborators

Swinburne University of Technology
Swinburne University of Technology, located in Melbourne, Australia, is known for its focus on innovation, industry engagement, and social inclusion.

Data attribution

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