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Идёт набор NCT06267183

A Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of SV001 in Chinese Healthy Adult Volunteers.

Ранняя фаза I С лечением Idiopathic Pulmonary Fibrosis

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: SV001, Placebo.
Кому может быть актуально
Состояния в реестре: Idiopathic Pulmonary Fibrosis. 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
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 I, Single-center, Randomized, Double-blind, Single-dose, Dose-ascending, Placebo-controlled Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of SV001 in Chinese Healthy Adult Volunteers.

Обзор

The purpose of this study is to evaluate safety, tolerability, PK and immunogenicity of SV001 compare to placebo in Chinese healthy adult volunteers.

Вмешательства

  • Препарат SV001
    SV001 ： single-dose
  • Препарат Placebo
    Placebo ： single-dose

Первичные конечные точки

  • Incidence of Treatment-Emergent Adverse Events [Срок оценки: Approximately 1 years]
Вторичные конечные точки (5)
  • Peak Plasma Concentration (Cmax) [Срок оценки: Approximately 1 years]
  • Peak time（Tmax） [Срок оценки: Approximately 1 years]
  • Area under the plasma concentration versus time curve (AUC) [Срок оценки: Approximately 1 years]
  • half-life（T1/2） [Срок оценки: Approximately 1 years]
  • Immunogenicity [Срок оценки: Approximately 1 years]

Критерии участия

Критерии включения

  • Subjects must fully understand the purpose, characteristics, methods and possible adverse reactions of the trial, volunteer as a subject, and sign the Informed Consent Form;
  • Subjects must have a Body Mass Index in the range of 19\~26 kg/m2, with males weighted not less than 50 kg, and females weighted not less than 45 kg;
  • Subjects must be in good health as judged by the investigator.
  • Reliable contraception must be assured during and for some time after the trial.

Критерии исключения

  • Subjects with a history of drug or other substance anaphylaxis;
  • Subjects with respiratory symptoms or abnormal respiratory tract;
  • Subjects currently having an oral disease that the investigator judged may affect use of the trial drug and devices;
  • Subjects with other diseases or factors with abnormal clinical manifestations;
  • Subjects having a history of drug abuse in the past or having used narcotics in the period prior to screening, or having a positive result in urine narcotics test at baseline period;
  • Subjects who smoked more than 5 cigarettes a day in the period before screening;
  • Subjects who consumed more than 14 units of alcohol per week in the period prior to screening, or who is positive in breath alcohol test at baseline period;
  • Subjects who have suffered a clinically significant severe disease or undergone major surgical operations within a certain period of time prior to receiving the investigational drug, or who are expected to require major operations during the clinical trial;
  • Subjects who used other drugs within a certain period of time before receiving the investigational drug;
  • Screening period: FEV1≤80% predicted value or FVC≤80% predicted value;
  • Subjects who have antibody positive for Human Immunodeficiency Virus, Hepatitis B surface antigen, Hepatitis C or Treponema Pallidum.
  • Subjects who have difficulty in venous blood collection or have a history of acupuncture syncope and blood phobia;
  • Female subjects who are tested positive for pregnancy during the screening or baseline period or are in lactation period;
  • Subjects who have participated in other drug clinical trials and used other drugs in clinical trials within a certain period of time before receiving the investigational drug;
  • Subjects who have a history of blood donation or blood loss of more than 400 mL in the period prior to screening;
  • Any other status in which the investigator deems inappropriate to participate in the present study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Shanghai Xuhui District Central Hospital — Шанхай

Идентификаторы

NCT: NCT06267183 · SV001-101

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗