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Идёт набор NCT07034183

A First-in-Human Study of PRD001

Фаза I С лечением Healthy Volunteers

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: PRD001, Placebo.
Кому может быть актуально
Состояния в реестре: Healthy Volunteers. Базовые параметры: 18 лет — 60 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Япония
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Последовательный дизайн
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

Япония · 1 центр
  • SOUSEIKAI Fukuoka Mirai Hospital — Fukuoka

Идентификаторы

NCT: NCT07034183 · PRD001-101-J

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗