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

Launched by JIANGSU HENGRUI MEDICINE CO., LTD. · Jan 9, 2025

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ClinConnect Summary

This clinical trial is investigating a new medication called RSS0343, which comes in tablet form, to see how safe and effective it is for people with non-cystic fibrosis bronchiectasis, a condition that affects the lungs and makes breathing difficult. The study aims to include adults aged 18 to 75 who have been diagnosed with this condition and have specific health requirements, such as having a certain weight and being free from certain other medical issues.

Participants in this trial will have the chance to take RSS0343 tablets and will be closely monitored by healthcare professionals to track their health and any side effects. It's important to note that the trial is not yet recruiting participants, and there are strict criteria for who can join, including not having certain lung diseases or infections. If you or someone you know is interested in learning more about this trial, it's a good idea to discuss it with a doctor to see if it might be a suitable option.

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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.