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The drug is reconstituted with sterile water for injection to the required concentration before use." } ], "sponsor": { "name": "Peking Union Medical College Hospital", "type": "OTHER" }, "locations": [ { "city": "Beijing", "country": "China", "facility": "Peking Union Medical College Hospital" } ], "outcomes": { "other": [ "Change in sweat chloride concentration measured by quantitative pilocarpine iontophoresis", "Change in daily sputum production volume", "Change in sputum solid content", "Incidence of treatment-related adverse events (TRAE) graded by CTCAE 6.0" ], "primary": [ "Incidence of adverse events (AE) and serious adverse events (SAE) assessed by CTCAE 6.0" ], "secondary": [ "Change in percent predicted forced expiratory volume in 1 second (ppFEV1) measured by spirometry", "Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) score" ] }, "eligibility": { "sex": "ALL", "criteria": "Inclusion Criteria:\n\n1. Aged 12 years and above (inclusive), regardless of gender.\n2. Voluntarily sign the informed consent form (legal guardians sign for minors \\<18 years old, with minor assent if needed).\n3. Confirmed diagnosis of cystic fibrosis (CF) with clinically stable condition.\n4. Weight ≥40 kg (≥18 years old) or ≥30 kg (\\<18 years old), or deemed eligible by the investigator.\n5. Predicted FEV1 ≥40% of the normal value and resting SpO2 ≥92% at screening.\n6. SAD trial participants: ≥3 months after last dose, no residual CFTR protein/mRNA in nasal epithelial cells (confirmed by lab tests).\n7. Quit smoking for at least 2 years.\n8. Willing and able to comply with all study procedures and follow-up plans.\n\nExclusion Criteria:\n\n1. Acute respiratory/pulmonary events, significant hemoptysis, or changed CF respiratory medications within 1 month before the first dose.\n2. Infected with highly virulent bacteria (e.g., \\*Burkholderia cepacia\\*, \\*Mycobacterium abscessus\\*), except for controllable colonization without clinical symptoms.\n3. 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