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NCT Number: NCT06775340

Study 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

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510140, China

Location status: Recruiting

Location contact

Weijie Guan

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

RSS0343 Tabella

Drug

RSS0343 tablets, oral;

Primary outcomes

  1. The number of occurrences of AEs

    Time frame: Day 1 to Day56

  2. the frequency of occurrence of AEs

    Time frame: Day 1 to Day56

Secondary outcomes

  1. RSS0343 amount of tablets of their metabolites in the blood

    Time frame: Day7, Day14, Day21, Day 28

  2. Changes in the concentrations of active neutrophil elastase (NE) in sputum

    Time frame: Day7, Day14, Day21, Day 28, Day 56

  3. Changes in the concentrations of cathepsin G (CatG) in sputum

    Time frame: Day7, Day14, Day21, Day 28, Day 56

  4. Changes in the concentrations of enzyme protease 3 (PR3) in sputum

    Time frame: Day7, Day14, Day21, Day 28, Day 56

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 15, 2025
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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