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.

Topic Healthy Subjects Safety
Compound Psilocybin
Country Australia
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Trial Details



Trial Number

Sponsors & Collaborators

Tryp Therapeutics
Tryp Therapeutics is a clinical stage drug development company developing psilocybin products for various diseases/disorders including fibromyalgia.

Data attribution

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