Evaluating RSS0343 Tablets for Non-cystic Fibrosis Bronchiectasis

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

This study is testing if RSS0343 tablets can improve lung function and health in adults with non-cystic fibrosis bronchiectasis.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 252 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06775340 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, pharmacodynamics, and efficacy of RSS0343 tablets in patients diagnosed with non-cystic fibrosis bronchiectasis. Participants aged 18 to 75 will be monitored for their response to the treatment, with a focus on improving lung function and overall health. The study aims to gather data that could lead to better management options for this condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with confirmed non-cystic fibrosis bronchiectasis and expected survival of more than 12 months.

Not a fit: Patients with primary diagnoses of pulmonary hypertension, COPD, or asthma, as well as those with active respiratory infections, will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from non-cystic fibrosis bronchiectasis.

How similar studies have performed: While this approach is novel for non-cystic fibrosis bronchiectasis, similar studies in related respiratory conditions have shown promising results.

Eligibility criteria

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.

Where this trial is running

Guangzhou, Guangdong

• First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Zi Lin

Conditions Adolescent Asthma