First-in-human testing of PRD001

A First-in-Human Study of PRD001 in Healthy Participants, Assessment of Safety, Tolerability and Pharmacokinetics of Single/Multiple Doses

This study will test PRD001's safety, tolerability, and how the body processes it in healthy adults and people with mild high LDL cholesterol and mild fatty liver.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 86 (estimated)
• Ages: 18 Years to 60 Years
• Sex: Male
• Sponsor: PRD Therapeutics, Inc. (industry)
• Locations: 1 site (Fukuoka, Fukuoka)
• Trial ID: NCT07034183 on ClinicalTrials.gov

What this trial studies

This Phase 1, first-in-human interventional study gives ascending doses of PRD001 or placebo in cohort-based administration to characterize safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD). The trial enrolls healthy volunteers and separate cohorts with borderline/mild hyper-LDL-cholesterolemia and mild fatty liver, with intensive monitoring including lab tests, ECGs, and clinical exams. Participants will attend scheduled clinic visits for blood sampling, safety assessments, and follow-up to define dose-related effects and PK/PD profiles. Dose-escalation decisions are guided by safety and PK data collected during the study.

Who should consider this trial

Good fit: Ideal candidates are adults who are healthy or have borderline/mild high LDL cholesterol and mild fatty liver, meet the study age and ancestry criteria, and can attend the Fukuoka study site.

Not a fit: People with moderate-to-severe liver disease, significantly elevated LDL that requires treatment, pregnant or breastfeeding individuals, older adults outside the enrollment ages, or those taking conflicting medications are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, PRD001 could identify a safe dose and dosing schedule and support development of a therapy to lower LDL cholesterol and address mild fatty liver disease.

How similar studies have performed: Other first-in-human trials of novel lipid-lowering or liver-targeted agents have successfully defined safety and dosing but require later-phase trials to confirm clinical benefit.

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.

Where this trial is running

Fukuoka, Fukuoka

• SOUSEIKAI Fukuoka Mirai Hospital — Fukuoka, Fukuoka, Japan (RECRUITING)

Conditions: Healthy Volunteers