Respiratory Syncytial Virus
Conditions
Interventions
YKYY018 group:Nebulized inhalation
YKYY018Placebo group:Nebulized inhalation
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Subject must voluntarily consent to participate in this study and provide their written informed consent prior to start of any study-specific procedures. 2. Subject must be between 18 and 55 years of age (inclusive), male or female. 3. Subject’s body mass index (BMI) must be between 19 and 27 kg/m^2 (inclusive). The body weight should be >= 50 kg for men and >= 45 kg for women. 4. Subject must be a non-smoker or having quit smoking for at least 3 months. 5. Subjects who can accept nasal irrigation with a nasal irrigator. 6. Female subjects have a negative pregnancy test result at screening and Day -1. All subjects (and female partners of childbearing potential of male subjects) must agree to use highly effective contraception (abstinence, prior sterilization, hormonal and/or barrier methods) from at least 1 month before screening (3 months for oral contraceptives), throughout the study period, and for 3 months after administration of the investigational product. Additionally, they must not donate ova or sperm during this period. 7. Subject must demonstrate ability to use a nebulizer effectively.
Exclusion criteria
Exclusion criteria: 1. Subjects with a medical history or presence of clinically significant respiratory system (e.g., asthma, chronic obstructive pulmonary disease [COPD], pulmonary fibrosis, hemoptysis, bronchiectasis, rhinitis, sinusitis, and allergic pharyngitis), hematological system, circulatory system, digestive system, urinary system, nervous system, immune system, endocrine system, or psychiatric disease or any other condition that, in the opinion of the physician, would jeopardize the safety of the subject or the validity of the study results; 2. Subjects have an abnormal result judged by the physician during the screening or baseline period to be clinically significant in physical examination, vital signs examination, or laboratory examinations, or if participation in the study poses an unacceptable risk. Additionally, subjects who meet the following laboratory parameters are also excluded: ALT or AST > 1.5 × upper limit of normal (ULN); Total bilirubin > 1.5 × ULN; Serum creatinine > ULN. 3. Subjects have an abnormal result judged by the physician to be clinically significant in chest X-ray test; 4. Subjects have an abnormal result judged by the physician to be clinically significant in the 12-lead electrocardiogram, or the adjusted QTc interval value 450 ms; 5. Subjects with a potential risk of airway hyperresponsiveness, such as long-term exposure to dust or harmful gases; 6. Subjects have FEV1 less than 80% predicted, forced vital capacity (FVC) ?80% predicted, FEV1/FVC=8 cups/day (1 cup = 250 mL)] within 3 months prior to randomization, or intake of foods or beverages containing caffeine (e.g., coffee, strong tea, co
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events ;Vital signs;Physical examination;12-lead ECG;Pulmonary function tests;Clinical laboratory test values;Immunogenicity assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic evaluation; | — |
Countries
China
Contacts
Public ContactHaiyan LI/Xiaohong Wang
Peking University Third Hospital
Outcome results
None listed