Actively Recruiting
Study of RSS0343 Tablets in Patients With Non-cystic Fibrosis Bronchiectasis
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2025-05-13
252
Participants Needed
1
Research Sites
149 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Studies to evaluate the safety, tolerability, pharmacodynamics, and efficacy of RSS0343 tablets in patients with non-cystic fibrosis bronchiectasis
CONDITIONS
Official Title
Study of RSS0343 Tablets in Patients With Non-cystic Fibrosis Bronchiectasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-75 years old (including boundary values), male and female.
- Female subjects weigh 645 kg and male subjects weigh 650 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.
You will not qualify if you...
- 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 psoriasis or lichen planus.
- Have Wright's disease/keratosis or hemorrhagic keratosis, or reactive arthritis.
- Have chlorine acne, large common warts, or keratodermatitis.
- Has diabetic foot.
- Have periodontal disease, oral infection, or loose teeth.
- History of malignant tumor within 5 years prior to screening.
- 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.
- Researchers consider any other unstable clinical disease.
- 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.
- Active hepatitis B virus infection, active hepatitis C virus infection, or known HIV infection or known syphilis infection.
- Drug abusers.
- Current smoker or former smoker for less than 3 months.
- Suspected allergy to the investigational product or any component of the investigational product, or severe allergy to any drug, food, toxin or other exposure.
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510140
Actively Recruiting
Research Team
Z
Zi Lin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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