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

NCT06965751 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-05-05

No results posted yet for this study

Summary

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).

Conditions

  • COVID-19 Infection

Interventions

DRUG

PDI204

PDI204 is a fully human, immunoglobulin G1 (IgG1) monoclonal antibody (mAb) directed against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein

OTHER

0.9 % saline

0.9% saline used as placebo

Sponsors & Collaborators

Principal Investigators

  • Stephen Kent, PhD, MD · University of Melbourne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-27
Primary Completion
2026-07-31
Completion
2026-08-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06965751 on ClinicalTrials.gov