A Prospective, Single-center, Open-label Clinical Study to Evaluate the Safety and Efficacy of Inhaled BMD003(CFTR mRNA) in Chinese Adult Patients With Cystic Fibrosis

Exclusion Criteria

• •1. Acute respiratory infection, acute exacerbation of lung disease, clinically significant hemoptysis (\>30 mL, or as determined by the investigator), or changes in respiratory medications (including antibiotics, oral steroids, etc.) used to treat CF occurred within 4 weeks prior to the first administration;
• •2. Infected with highly virulent bacteria associated with accelerated decline in lung function and/or shortened survival time (e.g. Burkholderia cepacia, Mycobacterium abscesses). For subjects with a positive culture history, they can be considered uninfected according to the following guidelines:
• •All culture results obtained in the past 12 months have been negative. Subject should have undergone at least 2 cultures within the past 12 months, with a minimum interval of 3 months between each culture, and at least one culture should have been conducted within 6 months prior to screening in this study.
• •3. During screening, the 12 lead electrocardiogram showed prolonged QTcF interval (\>450 ms for males and\>460 ms for females) and clinically significant abnormalities in other indicators of the 12 lead electrocardiogram.
• •4. During screening, total bilirubin exceeded the upper limit of normal, ALT and AST exceeded three times the upper limit of normal, and blood creatinine (CRE) was ≥ 1.5 times the upper limit of normal.
• •5. History of physical organ or blood transplantation or registered waiting for transplantation;
• •6. During screening, positive for human immunodeficiency virus antibodies (HIV Ab) and positive for Treponema pallidum specific antibodies (TPPA);
• •7. Participated in inhalation drug or device studies within 30 days prior to the initial screening visit (a 30 day window period applies to inhalation drugs with elimination half-life\<6 days. If the elimination half-life of inhalation drugs is ≥ 6 days, the window period should be extended to at least 5 half lives after the last administration);
• •8. Pregnant (positive blood pregnancy test result) or lactating women;
• •9. Having a history of drug allergies or other allergies, which investigators consider to be contraindications for participation in the study;
• •10. History of drug allergies or other allergies, and investigators believe it contraindications for participation in the study;
• •11. Investigators believe that any medical indicators (including other laboratory test indicators with clinical significance) or other conditions that may affect clinical trials.