Paediatric respiratory syncytial virus pneumonia
Conditions
Interventions
First dose group:The first 5 subjects were enrolled and only one time point of alveolar lavage was collected from each subject (each subject had a different time point). Based on the results of the fi
PK blood sample collection: within 60 min prior to dosing, 30 min ± 2 min, 60 min ± 2 min, 2 h ± 3 min, 4 h ± 5 min, 6 h ± 5 min, 12 h ± 10 min after the end of dosing
Bronchoalveolar lavage fluid sample collection: 1 h±30 min, 2 h±30 min, 4 h±30 min, 6 h±30 min, 12 h±30 min after the end of dosing for collection, 4 subjects at each point, each subject receiving bro
Recording of combined medication/treatment
Recording of adverse events
Second dose group:Nebulised inhalation of human interferon alpha 1b inhalation solution at a dose of 1.8 million IU once
Sponsors
Clinical Trial Center of Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy adult Chinese men or women aged 18 to 45 years; 2. weight = 45 kg for females and = 50 kg for males with a body mass index (BMI) of 19.0-26.0 kg/m2 (including upper and lower limits), BMI = weight (kg)/height2 (m2); 3. Subjects voluntarily participate in the trial and sign an informed consent form prior to the start of the study.
Exclusion criteria
Exclusion criteria: 1. have participated in any clinical trial of a drug or used an investigational drug within 3 months prior to the use of the investigational drug 2. who have undergone surgery within 3 months prior to screening or who are scheduled to undergo surgery during the study period, or who have undergone surgery that would interfere with the absorption, distribution, metabolism, or excretion of the drug; who have a history of prior clinically significant disease of the cardiovascular system, hematologic and lymphatic system, respiratory system, urinary system, endocrine, immunologic, psychiatric, or neurologic system (e.g., epilepsy) 3. history of respiratory disease such as acute exacerbation of chronic obstructive pulmonary disease, pulmonary fibrosis, pulmonary hypertension, pulmonary oedema, interstitial lung lesions, bronchial asthma, paradoxical bronchospasm, or pharyngeal ulceration, oedema, or previous pharyngeal, tracheal/bronchial and pulmonary surgery, or history of viral or bacterial-induced upper or lower respiratory tract infection, acute sinusitis, within 4 weeks prior to the administration of study drug and who, in the opinion of the investigator, are clinically significant or unfit to participate in the trial; 4. a history of nasal or pharyngeal disease or thyroid-related disease which, in the opinion of the investigator, is clinically significant or inappropriate for trial participation 5. a history of drug allergy (antibiotics, lidocaine or equivalent anaesthetic drugs, interferon products, relevant solution formulation ingredients, etc.), or a history of specific allergies (asthma, urticaria, eczema, etc.), or allergies (e.g. allergy to two or more drugs, foods, pollen, etc.) 6. people who cannot tolerate nebulised inhalation administration 7. a history of psychiatric illness such as confined space panic 8. use of any prescription medication, over-the-counter medication, herbal remedies or vitamins within 14 days prior to screening 9. have been vaccinated within 4 weeks prior to the first dose, or are scheduled to be vaccinated within 4 weeks of the last dose 10. who have lost = 300 ml of non-physiological blood (including trauma, blood collection, blood donation) within 3 months prior to the first dose; or who plan to donate blood during the trial or within 30 days of the last dose 11. history of drug or substance abuse within 6 months prior to screening 12. smokers within 3 months prior to screening, or unable to stop using any tobacco-based products during the trial 13. who have consumed more than 14 drinks (1 drink = 150 ml of wine, or 360 ml of beer, or 45 ml of spirits) per week in the 3 months prior to screening 14. persons who cannot tolerate venipuncture blood collection or who have potential difficulties with blood collection or who suffer from blood or needle sickness 15. those who cannot tolerate bronchoalveolar lavage 16. those who have special dietary requirements and cannot comply with a uniform diet 17. those who are planning to have children during the study period and within 3 months of the last dose, or are unable to voluntarily use effective contraception, or are planning to donate sperm/eggs; female subjects who are pregnant or breastfeeding 18. physical examination, ECG, vital signs, CT lung, laboratory tests with abnormalities in all tests of clinical significance (as judged by the clinician) 19. pulmonary function tests: those with FEV1 measured/FEV1 expected value = 80% or FVC = 80% of e
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local pharmacokinetics: concentrations of human interferon a1b in alveolar epithelial lining fluid (ELF) and alveolar macrophages (AM) levels.;Cmax;Tmax;AUC0-t; | — |
Secondary
| Measure | Time frame |
|---|---|
| AE;Vital signs;Twelve-lead electrocardiogram;ADA; | — |
Countries
China
Contacts
Public ContactGuoping Yang
Clinical Trial Center of the Third Xiangya Hospital of Central South University
Outcome results
None listed