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Идёт набор NCT06823947

Study of KK3910 in Healthy Volunteers and Patients With Essential Hypertension

Фаза I С лечением Healthy Volunteers Essential Hypertension

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: Placebo, KK3910.
Кому может быть актуально
Состояния в реестре: Healthy Volunteers Essential Hypertension. Базовые параметры: 18 лет — 80 лет · Все.
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 Phase 1, Placebo-Controlled, Double-Blind, Randomized, Single and Multiple Ascending-Dose Study of KK3910 in Healthy Volunteers and Patients With Essential Hypertension

Обзор

Part 1 : To evaluate the safety of single-dose KK3910 in healthy volunteers. Part 2 : To evaluate the safety of multiple-dose KK3910 in patients with essential hypertension. Part 3 : To assess the safety profile of repeated dosing of KK3910 in an additional hypertension cohort.

Вмешательства

  • Препарат Placebo
    Placebo is administered single dose or multiple dose by SC injection.
  • Препарат KK3910
    KK3910 is administered single dose or multiple dose by SC injection.

Первичные конечные точки

  • Number of participants with adverse events (AEs) [Срок оценки: Part 1 : Day 1 to Day 85, Part 2: Day 1 to Day 155, Part 3: Day 1 to Day 155]
Вторичные конечные точки (3)
  • Time to the maximum concentration [Срок оценки: Part 1 : Day 1 to Day 85, Part 2 : Day 1 to Day 155, Part 3: Day 1 to Day 155]
  • The maximum concentration [Срок оценки: Part 1 : Day 1 to Day 85, Part 2 : Day 1 to Day 155, Part 3: Day 1 to Day 155]
  • Area under the concentration-Time curve [Срок оценки: Part 1 : Day 1 to Day 85, Part 2 : Day 1 to Day 155, Part 3: Day 1 to Day 155]

Критерии участия

Inclusion Criteria: Part 1

  • Voluntary consent to participate in this study must be given (in writing)
  • Japanese healthy adults or non-Asian healthy men 18 to < 55 years at the time of informed consent ( Japanese healthy adults 65 to < 80 years for the elderly cohort)
  • BMI is within the specified range at screening

Inclusion Criteria: Part 2

  • Voluntary consent to participate in this study must be given (in writing)
  • Japanese patients with essential hypertension, aged 18 to <65 years at the time of informed consent
  • BMI is within the specified range at screening

Inclusion Criteria: Part 3

  • Voluntary consent to participate in this study must be given (in writing)
  • Japanese patients with essential hypertension, aged 18 to <80 years at the time of informed consent
  • BMI is within the specified range at screening

Exclusion Criteria: Part 1

  • History of any respiratory disease, heart disease, gastrointestinal disease, renal disease, liver disease, psychiatric disorder, autoimmune disease, or malignant tumor that may affect assessments in the study, as judged by principal investigator or subinvestigator.
  • History of or current drug allergy
  • History of or current alcoholism or drug addiction
  • Smoking within the specified period
  • infection within the specified period
  • Any condition judged by the investigator or subinvestigator to be unsuitable for participation in the study

Exclusion Criteria: Part 2

  • History of any respiratory disease, heart disease, gastrointestinal disease, renal disease, liver disease, psychiatric disorder, autoimmune disease, or malignant tumor that may affect assessments in the study, as judged by principal investigator or subinvestigator.
  • History or of current drug allergy
  • History of or current alcoholism or drug addiction
  • Pregnant or breastfeeding patients, or patients willing to have a child during the study
  • Smoking within the specified period
  • infection within the specified period
  • Any condition judged by the investigator or subinvestigator to be unsuitable for participation in the study

Exclusion Criteria: Part 3

  • History of any respiratory disease, heart disease, gastrointestinal disease, renal disease, liver disease, psychiatric disorder, autoimmune disease, or malignant tumor that may affect assessments in the study, as judged by principal investigator or subinvestigator.
  • History or of current drug allergy
  • History of or current alcoholism or drug addiction
  • Pregnant or breastfeeding patients, or patients willing to have a child during the study
  • Smoking within the specified period
  • infection within the specified period
  • Any condition judged by the investigator or subinvestigator to be unsuitable for participation in the study

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
Тройное слепое
Основная цель
Лечение

Центры проведения

Япония · 3 центра
  • SOUSEIKAI PS Clinic — Hakata
  • Medical Corporation Heishinkai OPHAC Hospital — Yodogawa
  • Kitasato University Kitasato Institute Hospital — Minato-ku

Идентификаторы

NCT: NCT06823947 · 3910-001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗