A Study on the Effects in Healthy People of a New Drug Called PDI204 for Treating COVID-19 (NCT06965751) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study on the Effects in Healthy People of a New Drug Called PDI204 for Treating COVID-19
Australia32 participantsStarted 2025-06-27
Plain-language 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).
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The absence of clinically significant illness and surgery within 4 weeks prior to study drug administration.
. The absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease. Fully resolved basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) are acceptable.
. post-menopausal (spontaneous amenorrhea for at least 12 months prior to dosing) with confirmation by documented FSH levels 40 mIU/mL or greater; or
. surgically sterile (bilateral oophorectomy or hysterectomy) at least 3 months prior to dosing.
Exclusion criteria
. Any clinically significant abnormal finding at physical examination.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The safety and tolerability of a single IV or IM dose of PDI204 in healthy adult participants
. Clinically significant abnormal laboratory test results or positive serology test results for HBsAg, HCV antibody, or HIV antigen and antibody, or QuantiFERON®-TB test at screening. Per Investigator's discretion, a single repeat for safety laboratory assessment to confirm initial result and trending is allowed per investigator's discretion.
. Positive pregnancy test or lactating female participant.
. Positive urine drug screen, or alcohol breath test.
. History of significant allergic reactions (e.g., anaphylactic reaction, hypersensitivity, angioedema) to any drug, in the opinion of investigator.
. Clinically significant ECG abnormalities or vital signs abnormalities (systolic BP lower than 90 or over 140 mmHg, diastolic BP lower than 40 or over 90 mmHg, HR less than 40 or over 100 bpm, or RR less than 10 or over 22 bpm) at screening.
. History of drug abuse within 1 year prior to screening or recreational use of soft drugs (such as marijuana) within 1 month or hard drugs (such as cocaine, phencyclidine \[PCP\], crack, opioid derivatives including heroin, and amphetamine derivatives) within 3 months prior to screening. per investigator's discretion, a single repeat for drug abuse urine test in the event of a false positive is allowed.
. History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 14 units for women and 21 units for men of alcohol per week (1 unit = 200 mL of beer 5%, 83 mL of wine 12%, or 25 mL of distilled alcohol 40%).