NCT06775340招募中2 期
Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of RSS0343 Tablets in Patients With Non-cystic Fibrosis Bronchiectasis
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- The number of occurrences of AEs
研究概览
简要总结
Studies to evaluate the safety, tolerability, pharmacodynamics, and efficacy of RSS0343 tablets in patients with non-cystic fibrosis bronchiectasis
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
RSS0343 Tabella
Experimental
干预措施: RSS0343 Tabella (Drug)
结局指标
主要结局
The number of occurrences of AEs
时间窗: Day 1 to Day56
the frequency of occurrence of AEs
时间窗: Day 1 to Day56
次要结局
- Changes in the concentrations of enzyme protease 3 (PR3) in sputum(Day7, Day14, Day21, Day 28, Day 56)
- RSS0343 amount of tablets of their metabolites in the blood(Day7, Day14, Day21, Day 28)
- Changes in the concentrations of cathepsin G (CatG) in sputum(Day7, Day14, Day21, Day 28, Day 56)
- Changes in the concentrations of active neutrophil elastase (NE) in sputum(Day7, Day14, Day21, Day 28, Day 56)
研究者
研究点 (1)
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