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Studies to evaluate the safety, tolerability, pharmacodynamics, and efficacy of RSS0343 tablets in patients with non-cystic fibrosis bronchiectasis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RSS0343 Tabella | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSS0343 Tabella | Drug | RSS0343 tablets, oral; |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of occurrences of AEs | Day 1 to Day56 | |
| the frequency of occurrence of AEs | Day 1 to Day56 |
| Measure | Description | Time Frame |
|---|---|---|
| RSS0343 amount of tablets of their metabolites in the blood | Day7, Day14, Day21, Day 28 | |
| Changes in the concentrations of active neutrophil elastase (NE) in sputum | Day7, Day14, Day21, Day 28, Day 56 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zi Lin | Contact | +0518-81220121 | zi.lin.zl30@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 510140 | China |
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| Changes in the concentrations of cathepsin G (CatG) in sputum | Day7, Day14, Day21, Day 28, Day 56 |
| Changes in the concentrations of enzyme protease 3 (PR3) in sputum | Day7, Day14, Day21, Day 28, Day 56 |