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

This Phase I, open-label, dose-escalation study (n=9) aims to assess the safety and pharmacokinetics of a single intravenous infusion of psilocin (active metabolite of psilocybin; TRP-8803; 8-21mg) in healthy adult participants.

Three cohorts of participants will receive escalating doses of psilocin, with a loading dose followed by a maintenance infusion. Safety will be closely monitored, with dose escalation contingent on safety reviews. The study will evaluate the safety profile, pharmacokinetics, and the psychedelic experience post-dose.

Eligible participants must be medically stable, between 18 to 55 years old, and meet various criteria regarding health status, lifestyle, and medication history. Recruitment for this trial is anticipated to commence on 24/05/2024 in South Australia, Australia, with Tryp Therapeutics, Inc. funding the study.

The trial is approved by the Bellberry Human Research Ethics Committee A in Australia. Dr. Sepehr Shakib from Cmax Clinical Research serves as the principal investigator, with Mr. Daniel Engeler and Dr. James Gilligan as contacts for public and scientific queries, respectively. Data sharing is not planned for individual participant data, and no summary results are available at this time.

Trial Details

Psilocin (4-Hydroxy-N,N-dimethyltryptamine) is the active form of the prodrug psilocybin (3[2(dimethylamino) ethyl]-1H-indol-4-yl] dihydrogen phosphate). Psilocybin is a natural product produced by numerous species of Psilocybe mushrooms. In humans, psilocybin is not detectable in systemic circulation or in target organs after oral administration as the phosphate group of psilocybin (a tryptamine derivative) is rapidly enzymatically cleaved to the active pharmacologic moiety psilocin . Thus, studies administering psilocybin are by default results for psilocin due to the almost immediate conversion of psilocybin to the active form psilocin. Administration of TRP8803 IV over a controlled time has potential advantages over oral administration of psilocybin such as improved control over blood levels of psilocin, faster entry into the psychedelic state, better control over the duration of the psychedelic state, and increased safety due to rapid offset of effects and avoidance of peak blood levels (Cmax) associated with oral administration. From a clinical research perspective TRP-8803 provides a mechanism to explore both the depth and duration of the psychedelic experience and how these parameters affect clinical outcomes. Infusing TRP-8803 with a bolus over the first 20 minutes (loading dose) allows attainment of Cmax in a controlled protocol and subsequent infusions for a total of 7.5, 14, or 20.5 mg over 140 minutes allows for maintenance of the psychedelic experience at a therapeutic dose. IV administration allows for the physician to control and optimize the psilocin dose.

NCT Number ACTRN12624000547549

Data attribution

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