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Recruiting NCT06775340

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

Phase II Interventional Adolescent Asthma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RSS0343 Tabella.
Who it may be relevant to
Registry conditions: Adolescent Asthma. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Drug RSS0343 Tabella
    RSS0343 tablets, oral;

Primary outcome measures

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

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • First Affiliated Hospital of Guangzhou Medical University — Guangzhou

Identifiers

NCT: NCT06775340 · RSS0343-201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗