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 trial (n=9) aims to evaluate the safety and pharmacokinetics of a single intravenous infusion of TRP-8803 (psilocin) in healthy adult participants.

The trial involves three cohorts, each comprising three participants, who will receive escalating doses of psilocin. Safety will be assessed through monitoring adverse events, physical examination, vital signs, ECG, and clinical laboratory findings. Pharmacokinetic data will be collected through plasma concentration measurements.

Participants must meet specific criteria, including being medically stable, aged between 18 and 55 years, and refraining from certain substances before and during the study.

The trial is sponsored by Tryp Therapeutics, Inc., and is conducted in Australia. It was registered on ANZCTR with the registration number ACTRN12624000547549. The trial’s primary purpose is treatment, and it is in phase I.

Topic Healthy Subjects
Compound Psilocybin
Country Australia
Visit trial

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

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.