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NCT06775340 | RECRUITING | Adolescent Asthma

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

Jiangsu H鞥R UI medicine co., Ltd.

Brief Summary:

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

Condition or disease

Adolescent Asthma

Intervention/treatment

RSS0343 Tabella

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 252 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of RSS0343 Tablets in Patients With Non-cystic Fibrosis Bronchiectasis
Actual Study Start Date : 2025-01-22
Estimated Primary Completion Date : 2027-11
Estimated Study Completion Date : 2027-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Study of RSS0343 Tablets in Patients With Non-cystic Fibrosis Bronchiectasis

Location Details

NCT06775340

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

China, Guangdong

First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China, 510140