Bacterial infectious diseases
Conditions
Interventions
Single-dose administration study:Single intravenous infusion administration
Multiple-dose studies:Multiple intravenous infusions for administration
Drug interaction research:Administer a single intravenous infusion per cycle
Sponsors
The Second Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1.Healthy subjects aged 18 to 45 years (including the threshold); 2.Weight >=50.0 kg for men and>=45.0 kg for women; body mass index (BMI) within the range of 19.0 to 26.0 kg/m^2 (including threshold values); 3.Subjects (including male subjects) do not plan to have children and voluntarily use effective contraception during the trial period and within 3 months after the last dose, and do not plan to donate sperm or eggs; 4.The subject fully understands the purpose and nature of the trial, the trial procedure, and possible adverse effects, volunteers as a subject, can communicate well with the investigator, complies with the requirements of the entire study, and signs an informed consent form prior to the commencement of any study procedures.
Exclusion criteria
Exclusion criteria: 1.Those with a history of specific allergies (e.g., urticaria) or who are allergic (e.g., known allergy to two or more medications), especially those with known allergies to cephalosporins/other beta-lactamases/sulfonamides, etc; 2.Those with a history of chronic or serious diseases of the circulatory, digestive, urinary, respiratory, hematologic, endocrine and metabolic, immune, and psychoneurological systems from 1 year prior to screening to enrollment; 3.Those with a glomerular filtration rate <90 mL/min; 4.Those with a previous history of kidney stones or kidney disease; 5.Physical examination, vital signs (ear temperature, pulse, respiratory rate, and blood pressure), laboratory tests (routine blood, urine, blood biochemistry, coagulation, and four items of infection), chest orthopantomographs, ultrasound of the urinary tract, and 12-lead electrocardiograms at the time of screening, with results that are clinically significant in the judgment of the investigator of the abnormality; Translated with www.DeepL.com/Translator (free version); 6.Anyone with an acute illness occurring between 2 weeks prior to screening and prior to enrollment; 7.Those who have used any medications (including any prescription drugs, over-the-counter drugs, herbs) and health supplements from 2 weeks prior to screening to enrollment; 8.Any drug that inhibits or induces hepatic metabolism of a drug (e.g., inducers-barbiturates, carbamazepine, phenytoin, glucocorticoids; depressants-SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, (fluoroquinolones, antihistamines, omeprazole) who are; 9.Those who cannot commit to stop consuming caffeine-containing beverages and foods (including chocolate, tea, coffee, cola, etc.) or foods that interfere with drug metabolism (including grapefruit, grapefruit products, dragon fruit, mango, pomelo, oranges, poppies, guava, etc.) 48 h prior to dosing until the end of the trial; 10.Those who have undergone major surgical procedures (excluding diagnostic surgical procedures) between 6 months prior to screening and enrollment, or who are scheduled to undergo surgery during the study period, or those who have undergone procedures that, in the judgment of the investigator, will affect drug absorption, distribution, metabolism, or excretion; 11.Persons who had received live attenuated vaccination 2 weeks prior to screening and up to enrollment or who required live attenuated vaccination during the trial; 12.Participants who have participated in other clinical trials from 3 months prior to screening to enrollment (Note: the end time is defined as the date of last participation in a clinical trial, and participation in a clinical trial of a drug is defined as the use of the drug used in the clinical study), or those who are not coming to participate in the clinical trial in person; 13.Those who have donated blood from 3 months prior to screening until enrollment, those who have lost a total of 400 mL or more of blood from blood donation or other causes from 6 months until enrollment (except for blood loss during physiological periods in females), or those who are planning to donate blood during the study period or within 3 months after the end of the study; 14.Drinking an average of more than 2 units of alcohol per week (1 unit = 360 mL of beer with 5% alcohol content or 45 mL of liquor with 40% alcohol content or 150 mL of wine with 12% alcohol content) 1 year prior t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic indicators;Security Indicators; | — |
Countries
China
Contacts
Public ContactWei Hu
The Second Hospital of Anhui Medical University
Outcome results
None listed