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Идёт набор NCT06775340

Study of RSS0343 Tablets in Patients With Non-cystic Fibrosis Bronchiectasis

Фаза II С лечением Adolescent Asthma

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: RSS0343 Tabella.
Кому может быть актуально
Состояния в реестре: Adolescent Asthma. Базовые параметры: 18 лет — 75 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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Официальное название

Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of RSS0343 Tablets in Patients With Non-cystic Fibrosis Bronchiectasis

Обзор

Studies to evaluate the safety, tolerability, pharmacodynamics, and efficacy of RSS0343 tablets in patients with non-cystic fibrosis bronchiectasis

Вмешательства

  • Препарат RSS0343 Tabella
    RSS0343 tablets, oral;

Первичные конечные точки

  • The number of occurrences of AEs [Срок оценки: Day 1 to Day56]
  • the frequency of occurrence of AEs [Срок оценки: Day 1 to Day56]
Вторичные конечные точки (4)
  • RSS0343 amount of tablets of their metabolites in the blood [Срок оценки: Day7, Day14, Day21, Day 28]
  • Changes in the concentrations of active neutrophil elastase (NE) in sputum [Срок оценки: Day7, Day14, Day21, Day 28, Day 56]
  • Changes in the concentrations of cathepsin G (CatG) in sputum [Срок оценки: Day7, Day14, Day21, Day 28, Day 56]
  • Changes in the concentrations of enzyme protease 3 (PR3) in sputum [Срок оценки: Day7, Day14, Day21, Day 28, Day 56]

Критерии участия

Критерии включения

  • Age 18-75 years old (including boundary values), male and female.
  • Female subjects weigh ≥45 kg and male subjects weigh ≥50 kg.
  • HRCT shows bronchiectasis affecting one or more lobes of the lung and is confirmed by the clinician as NCFB.
  • The expected survival is greater than 12 months.
  • Informed consent was signed before the trial.
  • Potentially fertile subjects voluntarily take appropriate contraceptive measures.

Критерии исключения

  • Patients with pulmonary hypertension or chronic obstructive pulmonary disease (COPD) or asthma as determined by the investigators were the primary diagnosis were screened.
  • An active, symptomatic infection caused by respiratory viruses, including COVID-19, influenza viruses, etc.
  • Have psoriasis or lichen planus.
  • Have Wright's disease/keratosis or hemorrhagic keratosis, or reactive arthritis.
  • Have chlorine acne, large common warts, or keratodermatitis.
  • Has diabetic foot.
  • Have periodontal disease, oral infection, or loose teeth.
  • History of malignant tumor within 5 years prior to screening.
  • Screening subjects with a history of liver disease or currently receiving treatment for liver disease, including but not limited to acute or chronic hepatitis, cirrhosis, or liver failure.
  • Researchers consider any other unstable clinical disease.
  • Oral or inhaled antibiotics were received 4 weeks prior to first administration.
  • Immunosuppressants were administered 4 weeks before the first dose.
  • Received drugs within 4 weeks prior to screening that may cause hyperkeratosis of the skin.
  • Received live attenuated vaccine within 30 days prior to initial administration.
  • Participated in clinical trials of any medical device within 3 months prior to screening.
  • Active hepatitis B virus infection, active hepatitis C virus infection, or known HIV infection or known syphilis infection.
  • Drug abusers.
  • Current smoker or former smoker for less than 3 months.
  • Suspected allergy to the investigational product or any component of the investigational product, or severe allergy to any drug, food, toxin or other exposure.
  • Pregnant or lactating women.
  • The subjects were unable to complete the questionnaires due to their limited educational level, or neither the subjects themselves nor their families could fill in the subject log card.
  • The researchers determined that there were other circumstances that were not suitable for participation in this study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • First Affiliated Hospital of Guangzhou Medical University — Гуанчжоу

Идентификаторы

NCT: NCT06775340 · RSS0343-201

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗