Respiratory syncytial virus infection
Conditions
Interventions
YKYY018 for Inhalation Solution:Dosage form: Inhalation preparation
Specification: 20mg (calculated by YKYY018) per bottle
Usage and dosage: A dose, nebulized inhalation
Medication schedule: Single d
Sponsors
The Third XiangYa Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Participants voluntarily participate in this study and sign a written Informed Consent Form (ICF) before any study-specific procedures begin; 2. Participants aged between 18 and 45 years (inclusive), regardless of gender, with both male and female participants included; 3. Participants have a Body Mass Index (BMI) between 19.0 and 27.0 kg/m^2 (inclusive), with male participants weighing >=50 kg and female participants weighing >=45 kg; 4. Female participants must have a negative pregnancy test during the screening period and on Day -1. Male participants and both male and female participants' partners of childbearing age must agree to use effective contraception (abstinence, prior sterilization, hormonal and/or barrier methods) for at least 1 month before screening (3 months if using oral contraceptives), during the study, and for 12 weeks after study drug administration, and must not donate eggs/sperm during this period; 5. Participants must be able to undergo bronchoalveolar lavage.
Exclusion criteria
Exclusion criteria: 1. A history or current history of clinically significant respiratory system conditions (such as asthma, chronic obstructive pulmonary disease [COPD], pulmonary fibrosis, hemoptysis, bronchiectasis, rhinitis, sinusitis, allergic pharyngitis, etc.), hematologic system, circulatory system, digestive system, urinary system, nervous system, immune system, endocrine system, or psychiatric disorders, or other diseases that the investigator believes may affect the safety of participants or the study results. 2. During the screening or baseline period, participants who have abnormalities in physical examination, vital signs, safety laboratory tests, or other auxiliary examinations, which are judged by the investigator to be clinically significant, or participation in the study would pose unacceptable risks, and meet the following laboratory criteria, should be excluded: (1) ALT, AST > 1.5 × upper limit of normal (ULN). (2) Total bilirubin > 1.5 × upper limit of normal (ULN). (3) Serum creatinine > upper limit of normal or estimated glomerular filtration rate (eGFR) =450 ms in males, >=460 ms in females [corrected by the Fridericia formula]) and judged by the investigator as unsuitable for study drug administration, presence of arrhythmias requiring drug treatment, or other ECG abnormalities deemed clinically significant by the clinician. 5. Those with a history of nasal, throat, or thyroid-related diseases, and who are deemed by the investigator to have clinical significance or are not suitable to participate in the trial; 6. Patients intolerant to nebulized inhalation therapy; 7. Those who cannot correctly use aerosol devices or inhalation administration and fail the training. 8. History of mental disorders such as claustrophobia. 9. Has special dietary requirements and cannot follow a standard diet. 10. Participants with a potential risk of airway hyperreactivity, such as those with long-term exposure to dust or harmful gases. 11. Forced Expiratory Volume in 1 Second (FEV1) < 80% of the predicted value, Forced Vital Capacity (FVC) < 80% of the predicted value, FEV1/FVC < 70%; or resting transcutaneous oxygen saturation < 95% in indoor air. 12. Positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), syphilis treponemal antibody (TP-Ab), or human immunodeficiency virus antibody (HIV-Ab). 13. Upper respiratory tract infection occurring within 1 month before the first administration. 14. Underwent major surgery within 6 months before the first dose or plans to undergo surgery during the study. 15. Use of any prescription drugs, over-the-counter drugs, vitamins, health supplements, and/or herbal products within 30 days prior to first administration. 16. Received any vaccine within 8 weeks before the first dose, or plans to receive a vaccine during the study. 17. Loss of blood or blood donation exceeding 400 mL within 3 months before the first dose, or planning to donate blood during the study. 18. Participated in any other clinical trial within the past 3 months. 19. History of drug abuse/illegal drug use, or any
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK profile of Alveolar epithelial lining fluid (ELF); | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events;Vital signs (pulse rate, blood pressure, body temperature, respiratory rate);Physical examination;12-lead Electrocardiogram;Clinical laboratory tests (complete blood count, blood biochemistry, urinalysis, and coagulation function);Plasma PK parameters;Incidence of Anti-Drug Antibody(ADA)and Neutralizing Antibody(NAb); | — |
Countries
China
Contacts
Public ContactMeng Jie/Yang Guoping
The Third XiangYa Hospital of Central South University
Outcome results
None listed