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 range18 Years – 65 Years
SexALL
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.
✕. 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.
✕
What they're measuring
1
The safety and tolerability of a single IV or IM dose of PDI204 in healthy adult participants
. 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%).