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

NCT06775340 | Recruiting Phase 2

• 1 other identifier: RSS0343-201
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Adolescent Asthma

Outcome Measures

Primary Outcomes (2)

• The number of occurrences of AEs

  Day 1 to Day56

• the frequency of occurrence of AEs

  Day 1 to Day56

Secondary Outcomes (4)

• 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

Study Arms (1)

RSS0343 Tabella

EXPERIMENTAL

Drug: RSS0343 Tabella

Interventions

RSS0343 Tabella DRUG

RSS0343 tablets, oral;

RSS0343 Tabella

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510140, China

RECRUITING

Central Study Contacts

Zi Lin

CONTACT

+0518-81220121; zi.lin.zl30@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 15, 2025
• Study Start: January 22, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 13, 2025

Record last verified: 2025-01

Locations

CN (1)