NCT07034183 A First-in-Human Study of PRD001
| NCT ID | NCT07034183 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | PRD Therapeutics, Inc. |
| Condition | Healthy Volunteers |
| Study Type | INTERVENTIONAL |
| Enrollment | 86 participants |
| Start Date | 2025-06-19 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 86 participants in total. It began in 2025-06-19 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of PRD001 in healthy participants and to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of PRD001 in participants with borderline/mild hyper-LDL-cholesterolemia and mild fatty liver.
Eligibility Criteria
Inclusion Criteria: * Part 1A and Part 2A 1. Healthy men aged between 18 and 45 years inclusive at the time of signing the informed consent form (ICF) 2. Individuals who are willing and able to comply with the protocol schedule, including all scheduled visits, treatment plans, laboratory tests, and other trial procedures. 3. Individuals who are able to participate in Part 1B following Part 1A, and are willing and able to comply with the protocol schedule, including all scheduled visits, treatment plans, laboratory tests, and other trial procedures. 4. Individuals who have no clinically significant findings, are generally healthy and have no disease requiring medical treatment, based on medical history, physical examinations, vital signs, 12-lead ECG, and laboratory test results at screening. 5. For Japanese participants in Part 1A and Part 2A, individuals whose parents and maternal and paternal grandparents are Japanese, and for Caucasian participants in Part 2A, individuals whose parents and maternal and paternal grandparents are Caucasian. * Part 1B Individuals who receive PRD001 in Part 1A and complete all specified visit schedules. * Part 2B 1. Men aged between 18 and 60 years inclusive at the time of signing the ICF 2. Individuals who are willing and able to comply with the protocol schedule, including all scheduled visits, treatment plans, laboratory tests, and other trial procedures. 3. Individuals who have no clinically significant findings, are generally healthy and have no disease requiring medical treatment (however, diet or exercise therapy is acceptable), based on medical history, physical examinations, vital signs, 12-lead ECG, and laboratory test results at screening. 4. Individuals whose parents and maternal and paternal grandparents are Japanese. 5. Individuals who meet the following criteria: i. Individuals with mild-hyper-LDL-cholesterolemia ii. Individuals with mild hepatic steatosis Exclusion Criteria: * All parts 1. Individuals with active, latent, or inadequately treated M. tuberculosis infection at screening who meet both of the following: i. A positive result on the QuantiFERON-TB Gold test or an equivalent test ii. Active tuberculosis infection that is untreated, inadequately treated, or currently being treated 2. Individuals with a history of human immunodeficiency virus (HIV) infection, syphilitic infection, hepatitis B or C at screening.
Frequently Asked Questions
Who can join the NCT07034183 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 60 Years, studying Healthy Volunteers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07034183 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07034183 currently recruiting?
Yes, NCT07034183 is actively recruiting participants. Visit ClinicalTrials.gov or contact PRD Therapeutics, Inc. to inquire about joining.
Where is the NCT07034183 trial being conducted?
This trial is being conducted at Fukuoka, Japan.
Who is sponsoring the NCT07034183 clinical trial?
NCT07034183 is sponsored by PRD Therapeutics, Inc.. The trial plans to enroll 86 participants.