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NCT06775340RecruitingPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 13 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
252 (estimated)
First submitted
9 Jan 2025
Start date
22 Jan 2025
Primary completion date
Nov 2027
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
NCT number
NCT06775340

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 252
  • From 22 Jan 2025 to the primary completion date, Nov 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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.

Other

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
First Affiliated Hospital of Guangzhou Medical University
Coordinator of this site? Confirm its status
GuangzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.