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

Korábbi kezelés

• 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.
• 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.
• Drug abusers.
• Suspected allergy to the investigational product or any component of the investigational product, or severe allergy to any drug, food, toxin or other exposure.

Más betegség

• 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 Wright's disease/keratosis or hemorrhagic keratosis, or reactive arthritis.
• Have periodontal disease, oral infection, or loose teeth.
• History of malignant tumor within 5 years prior to screening.
• Researchers consider any other unstable clinical disease.
• Active hepatitis B virus infection, active hepatitis C virus infection, or known HIV infection or known syphilis infection.

Egyéb

• Have psoriasis or lichen planus.
• Have chlorine acne, large common warts, or keratodermatitis.
• Has diabetic foot.
• Current smoker or former smoker for less than 3 months.
• Pregnant or lactating women.
• 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.
• The researchers determined that there were other circumstances that were not suitable for participation in this study.

• 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.