Study of RSS0343 Tablets in Patients With Non-cystic Fibrosis Bronchiectasis
ConditionAdolescent Asthma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJiangsu HengRui Medicine Co., Ltd.
About this trial
Studies to evaluate the safety, tolerability, pharmacodynamics, and efficacy of RSS0343 tablets in patients with non-cystic fibrosis bronchiectasis
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
RSS0343 Tabella
DrugRSS0343 tablets, oral;
Treatment groups
252 Participants
are divided into 1 treatment groupGroup A: RSS0343 TabellaExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The number of occurrences of AEs
Time frame
Day 1 to Day562
the frequency of occurrence of AEs
Time frame
Day 1 to Day56Secondary outcomes
1
RSS0343 amount of tablets of their metabolites in the blood
Time frame
Day7, Day14, Day21, Day 282
Changes in the concentrations of active neutrophil elastase (NE) in sputum
Time frame
Day7, Day14, Day21, Day 28, Day 563
Changes in the concentrations of cathepsin G (CatG) in sputum
Time frame
Day7, Day14, Day21, Day 28, Day 564
Changes in the concentrations of enzyme protease 3 (PR3) in sputum
Time frame
Day7, Day14, Day21, Day 28, Day 56Sponsors and contacts
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Source ClinicalTrials.gov