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

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

Study Overview

• Status: Recruiting
• Conditions: Adolescent Asthma
• Intervention / Treatment: Drug: RSS0343 Tabella

• Study Type: Interventional
• Enrollment (Estimated): 252
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zi Lin; Phone Number: +0518-81220121; Email: zi.lin.zl30@hengrui.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510140
      • Recruiting
      • First Affiliated Hospital of Guangzhou Medical University
      • Principal Investigator: Weijie Guan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18-75 years old (including boundary values), male and female.
2. Female subjects weigh ≥45 kg and male subjects weigh ≥50 kg.
3. HRCT shows bronchiectasis affecting one or more lobes of the lung and is confirmed by the clinician as NCFB.
4. The expected survival is greater than 12 months.
5. Informed consent was signed before the trial.
6. Potentially fertile subjects voluntarily take appropriate contraceptive measures.

Exclusion Criteria:

1. Patients with pulmonary hypertension or chronic obstructive pulmonary disease (COPD) or asthma as determined by the investigators were the primary diagnosis were screened.
2. An active, symptomatic infection caused by respiratory viruses, including COVID-19, influenza viruses, etc.
3. Have psoriasis or lichen planus.
4. Have Wright's disease/keratosis or hemorrhagic keratosis, or reactive arthritis.
5. Have chlorine acne, large common warts, or keratodermatitis.
6. Has diabetic foot.
7. Have periodontal disease, oral infection, or loose teeth.
8. History of malignant tumor within 5 years prior to screening.
9. 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.
10. Researchers consider any other unstable clinical disease.
11. Oral or inhaled antibiotics were received 4 weeks prior to first administration.
12. Immunosuppressants were administered 4 weeks before the first dose.
13. Received drugs within 4 weeks prior to screening that may cause hyperkeratosis of the skin.
14. Received live attenuated vaccine within 30 days prior to initial administration.
15. Participated in clinical trials of any medical device within 3 months prior to screening.
16. Active hepatitis B virus infection, active hepatitis C virus infection, or known HIV infection or known syphilis infection.
17. Drug abusers.
18. Current smoker or former smoker for less than 3 months.
19. Suspected allergy to the investigational product or any component of the investigational product, or severe allergy to any drug, food, toxin or other exposure.
20. Pregnant or lactating women.
21. 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.
22. The researchers determined that there were other circumstances that were not suitable for participation in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RSS0343 Tabella	Drug: RSS0343 Tabella; RSS0343 tablets, oral;

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The number of occurrences of AEs	Day 1 to Day56
the frequency of occurrence of AEs	Day 1 to Day56

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 9, 2025
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): January 15, 2025

Study Record Updates

• Last Update Posted (Actual): May 13, 2025
• Last Update Submitted That Met QC Criteria: May 12, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchiectasis
• Other Study ID Numbers: RSS0343-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No