Lung infections
Conditions
Interventions
A group:Single intravenous infusion of 1500mg of HRS-8427 for injection, with alveolar lavage fluid collected 2h after administration
B group:Single intravenous infusion of 1500mg of HRS-8427 for injection, with alveolar lavage fluid collected 3h after administration
C group:Single intravenous infusion of 1500mg of HRS-8427 for injection, with alveolar lavage fluid collected 5h after administration
D group:Single intravenous infusion of 1500mg of HRS-8427 for injection, with alveolar lavage fluid collected 8h after administration
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. Subjects who have signed an informed consent form prior to the trial and are fully aware of the content, procedure and possible adverse effects of the trial: participate voluntarily and are able to complete the study in accordance with the trial protocol. 2. Male or female subjects aged 18-45 years (including 18 and 45 years) 3. Male subjects weighing no less than 50.0 kg and female subjects weighing no less than 4.0 kg with a body mass index (BMI) within the range of 19.026.0 kg/m (including the threshold). 4. Female subjects of childbearing potential or male subjects whose partners are women of childbearing potential, who have no plans to have children or donate sperm/eggs for at least 3 months from the time of signing the informed consent until the end of the study, and who are voluntarily using highly effective contraception (including partners) (non-pharmaceutical contraception is required during the trial).
Exclusion criteria
Exclusion criteria: 1. Have had or are having a disease with abnormal clinical presentation prior to screening that needs to be excluded, including but not limited to neurological/psychiatric, respiratory, cardiovascular, gastrointestinal, hematological and lymphatic, urinary, endocrine, or immune system disorders. 2. Have undergone surgery within 3 months prior to screening or are scheduled to undergo surgery during the study period, and have undergone surgery that would affect the absorption, distribution, metabolism, or excretion of the drug. 3. have used any prescription, over-the-counter, herbal or vitamin medication within 2 weeks prior to screening 4. History of substance abuse or drug use within 6 months prior to screening. 5. History of food or drug allergy, especially known allergy or hypersensitivity to components of B-endoamines (including penicillin, carbapenems, cephalosporins, oxytetracycline, monocyclic B-endoamines, etc.). 6. Subjects with asthma or history of asthma. 7. Subjects with a history of lung-related disease, other diseases or clinically significant abnormalities in lung CT or pulmonary function tests that are judged by the investigator to be inappropriate or intolerable for alveolar bronchial lavage, e.g., 80% of the measured FEVI/FEV1 estimate or FVC = 80% of the estimate on pulmonary function tests. 8. Those who have received a vaccination within 1 month prior to screening, or those who are scheduled to receive a vaccination during the trial. 9. Blood donations including component blood or significant blood loss (=400mL) within 3 months prior to screening, or planned to donate blood during the trial 10. Have been enrolled in another clinical trial of a drug within 3 months prior to screening and are receiving clinical trial drugs. 11. Those who cannot tolerate venipuncture or have a history of needle or blood sickness. 12. smoked more than 5 cigarettes per day on average during the 3 months prior to screening, or were unable to stop using any tobacco products during the trial 13. Average weekly alcohol consumption greater than 14 units (1 unit of alcohol ˜ 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine) during the 3 months prior to screening, or inability to abstain from alcohol during the trial. 14. Excessive consumption of tea, coffee and/or caffeinated beverages (average of more than 8 cups, 1 cup ˜ 250m L) per day during the 3 months prior to screening. 15. who have consumed or consumed dragon fruit, mango, grapefruit, poppy seeds or foods or beverages prepared from them, or foods or beverages containing xanthines, caffeine or alcohol (including chocolate, tea, coffee, cola, cocoa, etc.), or other special diets that interfere with the absorption, distribution, metabolism or excretion of drugs within 48 days prior to admission 16. those who have special dietary requirements and cannot accept a uniform diet 17. female subjects who are pregnant or breastfeeding during the trial 18. those whose vital signs, physical examination, clinical laboratory tests, 12-lead electrocardiogram, abdominal ultrasound, lung CT, pulmonary function tests, etc. show abnormal results of clinical significance 19. Those who, in the opinion of the investigator, are unsuitable for participation in clinical trials. Anyone who meets one of the above conditions shall not be enrolled as a subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood sample peak concentration;Blood sample peak time;Adverse evens;Physical examination;laboratory test;Twelve-lead electrocardiogram;vital signs;Blood sample AUC0-t;Blood sample t1/2;Apparent volume of distribution of blood VZsample ;Blood Sample Apparent Clearance CLZ;Blood sample residual area percentage AUC_%Extrap;Blood sample AUC0-8;Alveolar epithelial lining fluid drug front concentration;Alveolar epithelial lining fluid Peak time Tmax;Alveolar epithelial lining fluid AUC0-t;Alveolar epithelial lining fluid AUC0-8;Alveolar epithelial lining fluid t1/2;Apparent volume of distribution of alveolar epithelial lining fluid;AUCELF/AUCplasma;CELF/Cplasma;Alveolar macrophage peak drug concentration;Alveolar macrophage Peak time;Alveolar macrophage AUC0-t;Alveolar macrophage AUC0-8;Alveolar macrophage t1/2;Alveolar macrophage apparent volume of distribution ;AUCAM/AUCplasma;CAM/Cplasma; | — |
Countries
China
Contacts
Public ContactGuoping Yang
Clinical Trial Center of the Third Xiangya Hospital of Central South University
Outcome results
None listed