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
Status Not yet recruiting
Results Published No
Start date 24 May 2024
End date 31 December 2026
Phase Phase I
Design Open
Type Interventional
Generation Second
Participants 9
Sex All
Age 18- 55
Therapy No

Trial Details

This phase I trial, sponsored by Tryp Therapeutics, Inc., aims to evaluate the safety and pharmacokinetics of a single intravenous infusion of TRP-8803 (Psilocin) in healthy adult participants. Psilocin will be administered in three cohorts, with each cohort comprising three participants who will receive different doses of psilocin via intravenous infusion. The trial will assess safety through monitoring adverse events and serious adverse events, while pharmacokinetics will be measured at designated times post-infusion. The study is non-randomised and not yet recruiting.

NCT Number ACTRN12624000547549

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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