Tests RSS0343 tablets in adults with non-cystic fibrosis bronchiectasis
Tests RSS0343 tablets for safety and effect in adults with bronchiectasis.
Plain-language title generated from the registry record
Registry title: Study of RSS0343 Tablets in Patients With Non-cystic Fibrosis Bronchiectasis
Key facts
- Where
- Guangzhou, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06775340, who can take part
Where in China
- First Affiliated Hospital of Guangzhou Medical UniversityGuangzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Jiangsu HengRui Medicine Co., Ltd.
- Trial code
- NCT06775340
- Record updated
- 13 May 2025
- Original description
Studies to evaluate the safety, tolerability, pharmacodynamics, and efficacy of RSS0343 tablets in patients with non-cystic fibrosis bronchiectasisRead full original descriptionShow less
Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of RSS0343 Tablets in Patients With Non-cystic Fibrosis Bronchiectasis
Studies to evaluate the safety, tolerability, pharmacodynamics, and efficacy of RSS0343 tablets in patients with non-cystic fibrosis bronchiectasis
Inclusion: 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.
Exclusion: 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; 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; Drug abusers; Suspected allergy to the investigational product or any component of the investigational product, or severe allergy to any drug, food, toxin or other exposure; 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 Wright's disease/keratosis or hemorrhagic keratosis, or reactive arthritis; Have periodontal disease, oral infection, or loose teeth; History of malignant tumor within 5 years prior to screening; Researchers consider any other unstable clinical disease; Active hepatitis B virus infection, active hepatitis C virus infection, or known HIV infection or known syphilis infection; Have psoriasis or lichen planus; Have chlorine acne, large common warts, or keratodermatitis; Has diabetic foot; Current smoker or former smoker for less than 3 months; 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.