A Study on the Effects in Healthy People of a New Drug Called PDI204 for Treating COVID-19

The goal of this clinical trial is to learn if a new drug called PDI204, developed for treating or preventing COVID-19, is safe and well-tolerated in healthy volunteers. This is a first-in-human study. The main questions it aims to answer are: Is PDI204 safe and well-tolerated in healthy people? How long for and how does the body interact with PDI204? Researchers will compare side effects in people who receive PDI204 and in those who receive a placebo (a look-alike substance that contains no drug) to see if and how many side-effects there are with PDI204. Researchers will also measure how long PDI204 can be detected in the blood. Participants will be asked to receive a single dose of PDI204. Participants will have to stay in the clinical center for the day of receiving the dose of PDI204 and will be discharged the next day. Participants will then need to come back to the clinical center for study visits on days 3, 5, 7 (+/-1), 15 (+/-1), 30 (+/-3), 60 (+/-3) and 90 (+/-7).

NCT Number	NCT06965751
Lead Sponsor	University of Melbourne Collaborators: Nucleus Network Ltd, Syneos Heath
Conditions	COVID-19 Infection
Enrollment	32 participants
Start Date	2025-06-27
Primary Completion	2026-07 (estimated)
Study Completion	2026-08 (estimated)
Updated on ClinicalTrials.gov	2026-05-05