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

NCT ID: NCT06775340

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 252 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-22
• Study Completion Date: 2027-12-31

Brief Summary

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

Conditions

Adolescent Asthma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RSS0343 Tabella

Group Type: EXPERIMENTAL

RSS0343 Tabella

Intervention Type: DRUG

RSS0343 tablets, oral;

Interventions

RSS0343 Tabella

RSS0343 tablets, oral;

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zi Lin

Role: CONTACT

zi.lin.zl30@hengrui.com

+0518-81220121

Other Identifiers

RSS0343-201

Identifier Type: -

Identifier Source: org_study_id