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Идёт набор NCT07232758

Safety, Tolerability and Pharmacokinetic Studies of HRS-2183 for Injection in Healthy Chinese Subjects After Single and Multiple Administration

Фаза I С лечением Chinese Healthy Adult Subjects

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: HRS-2183, Placebo.
Кому может быть актуально
Состояния в реестре: Chinese Healthy Adult Subjects. Базовые параметры: 18 лет — 45 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
Китай
Следующий шаг
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Обзор

This study mainly evaluated the safety and tolerability, as well as the pharmacokinetic characteristics, of the injectable drug HRS-2183 after single and multiple administrations in healthy subjects.

Вмешательства

  • Препарат HRS-2183
    HRS-2183
  • Препарат Placebo
    placebo

Первичные конечные точки

  • Incidence and severity of any adverse events [Срок оценки: Evaluation was performed up to the seventh day / the 16th day]
Вторичные конечные точки (12)
  • Tmax (Pharmacokinetic Parameters after a Single Dose) [Срок оценки: Evaluation was performed up to the third day]
  • Cmax(Pharmacokinetic Parameters after a Single Dose) [Срок оценки: Evaluation was performed up to the third day]
  • AUC0-t(Pharmacokinetic Parameters after a Single Dose) [Срок оценки: Evaluation was performed up to the third day]
  • AUC0-∞(Pharmacokinetic Parameters after a Single Dose) [Срок оценки: Evaluation was performed up to the third day]
  • t1/2(Pharmacokinetic Parameters after a Single Dose) [Срок оценки: Evaluation was performed up to the third day]
  • CLz(Pharmacokinetic Parameters after a Single Dose) [Срок оценки: Evaluation was performed up to the third day]
  • Vz(Pharmacokinetic Parameters after a Single Dose) [Срок оценки: Evaluation was performed up to the third day]
  • Ae0-t(Pharmacokinetic Parameters after a Single Dose) [Срок оценки: Evaluation was performed up to the third day]
  • Fe0-t(Pharmacokinetic Parameters after a Single Dose) [Срок оценки: Evaluation was performed up to the third day]
  • CLr(Pharmacokinetic Parameters after a Single Dose) [Срок оценки: Evaluation was performed up to the third day]
  • Tmax(Pharmacokinetic Parameters after Multiple Doses) [Срок оценки: Evaluation was performed up to the 12th day]
  • Cmin,ss(Pharmacokinetic Parameters after Multiple Doses) [Срок оценки: Evaluation was performed up to the 12th day]

Критерии участия

Критерии включения

  • Healthy male and female subjects, aged 18 to 45 years.
  • Body weight and Body Mass Index (BMI) within a specified range (e.g., BMI 19.0-26.0 kg/m²).
  • Agreement to use highly effective contraception during the study period and for a specified duration after the last dose. No plans for pregnancy, sperm/egg donation.
  • Voluntarily provides written informed consent to participate in the study.

Критерии исключения

  • History of significant allergies to any food or drug, especially to the investigational product, its components, or drugs of a similar class.
  • History or current presence of any clinically significant disease in major organ systems (e.g., cardiovascular, hepatic, renal, neurological, etc.).
  • Any clinically significant abnormalities found during screening assessments (including physical examination, vital signs, and laboratory tests).
  • Clinically significant abnormalities on 12-lead electrocardiogram (ECG) at screening.
  • Evidence of impaired renal function based on laboratory tests (e.g., eGFR, serum creatinine).
  • Positive screening for specified infectious diseases (e.g., HIV, HBV, HCV, Syphilis).
  • Use of any medication (including prescription, OTC, and herbal) within a specified period before the study.
  • Excessive consumption of certain beverages (e.g., caffeine, grapefruit juice) or inability to adhere to dietary restrictions.
  • History of major surgery within the past 3 months or planned surgery during the study period.
  • Participation in another clinical trial within the past 3 months.
  • Significant blood loss, blood donation, or transfusion within the past 3 months.
  • History of excessive alcohol consumption or unwillingness to abstain during the study.
  • History of heavy smoking or unwillingness to abstain during the study.
  • History of drug abuse or positive drug screening test.
  • Inability to tolerate venous access or history of fainting during blood draws.
  • Inability to comply with the standardized diet provided during the study.
  • Any other reason that, in the opinion of the investigator, makes the subject unsuitable for the study.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Qilu Hospital of Shandong University — Цзинань

Идентификаторы

NCT: NCT07232758 · HRS-2183-102

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗