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Recruiting NCT07034183

A First-in-Human Study of PRD001

Phase I Interventional Healthy Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PRD001, Placebo.
Who it may be relevant to
Registry conditions: Healthy Volunteers. Basic parameters: 18 years — 60 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug PRD001
    PRD001 capsules will be provided for oral administration
  • Drug Placebo
    Placebo capsules will be provided for oral administration

Primary outcome measures

  • Incidence of treatment-emergent AEs and SAEs as assessed by vital signs [Time frame: 42 days (treatment period: 28 days, observation period: 14 days)]

Eligibility criteria

Inclusion criteria

  • Part 1A and Part 2A
  • Healthy men aged between 18 and 45 years inclusive at the time of signing the informed consent form (ICF)
  • Individuals who are willing and able to comply with the protocol schedule, including all scheduled visits, treatment plans, laboratory tests, and other trial procedures.
  • 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.
  • 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.
  • 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
  • Men aged between 18 and 60 years inclusive at the time of signing the ICF
  • Individuals who are willing and able to comply with the protocol schedule, including all scheduled visits, treatment plans, laboratory tests, and other trial procedures.
  • 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.
  • Individuals whose parents and maternal and paternal grandparents are Japanese.
  • Individuals who meet the following criteria:

i. Individuals with mild-hyper-LDL-cholesterolemia ii. Individuals with mild hepatic steatosis

Exclusion criteria

  • All parts
  • 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

  • Individuals with a history of human immunodeficiency virus (HIV) infection, syphilitic infection, hepatitis B or C at screening.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Japan · 1 center
  • SOUSEIKAI Fukuoka Mirai Hospital — Fukuoka

Identifiers

NCT: NCT07034183 · PRD001-101-J

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗