infectious diseases
Conditions
Interventions
B:single dose i.v. infusion (dose level 2)
C:single dose i.v. infusion (dose level 3)
D:single dose i.v. infusion (dose level 4)
A:single dose i.v. infusion (dose level 1)
E:multi-dose i.v. infusion (dose level 5)
F:multi-dose i.v. infusion (dose level 6)
G:multi-dose i.v. infusion (dose level 7)
Sponsors
The Second Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects shall sign the informed consent before the test and have a full understanding of the test content, process and possible adverse reactions; Volunteer to participate and be able to complete the study according to the protocol; 2. Male or female subjects aged 18-45 years (including 18 and 45 years); 3. Male weight should not be less than 50.0 kg, female weight should not be less than 45.0 kg, body mass index (BMI) should be in the range of 19.0-26.0 kg/m^2 (including the critical value); 4. Has the fertile women subjects or partner for male subjects with fertile women, since signed informed consent to research for at least 3 months after the end of barren, donate sperm egg/plan, and voluntary to take effective contraceptive measures (including partner) (during the test required to take the pill).
Exclusion criteria
Exclusion criteria: 1. Pre-screening or ongoing diseases with abnormal clinical manifestations that need to be excluded, including but not limited to neurological/psychiatric, respiratory, cardiovascular, digestive, hematological and lymphatic, urinary, endocrine, and immune system diseases; 2. Volunteers who have undergone surgery within 3 months prior to screening or are scheduled to undergo surgery during the study period, and those who have undergone surgery that would affect the absorption, distribution, metabolism, or excretion of drugs; 3. Volunteers who have used any prescription, over-the-counter, herbal and vitamin medications within 2 weeks prior to screening; 4. Persons with a history of substance abuse or drug use within 6 months prior to screening; 5. History of allergy to food, drugs, etc., especially those known to be allergic to components of ß-lactam antibacterial drugs (including penicillin, carbapenems, cephalosporins, oxycephalenes, monocyclic ß-lactams, etc.) or those with allergies, or positive penicillin skin test results; 6. Those who have received the vaccine within 1 month prior to screening, or those who plan to receive the vaccine during the trial; 7. Blood donations including component blood or significant blood loss (>= 400 mL) within 3 months prior to screening, or planned to donate blood during the trial; 8. Enrolled in other drug clinical trials and received clinical trial drugs within 3 months prior to screening; 9. Those who cannot tolerate venipuncture or have a history of needle sickness or blood sickness; 10. Those who smoked an average of >5 cigarettes per day during the 3 months prior to screening or who were unable to stop using any tobacco products during the trial; 11. 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) in the 3 months prior to screening, or who cannot abstain from alcohol during the trial. 12. Excessive daily consumption of tea, coffee, and/or caffeinated beverages (average of more than 8 cups, 1 cup ˜ 250 mL) during the 3 months prior to screening. 13. Those who have consumed or drunk dragon fruit, mango, grapefruit, poppy seeds or food or beverages prepared from them, or food or beverages containing xanthines, caffeine or alcohol (including chocolate, tea, coffee, cola, cocoa, etc.), or other special diets that affect the absorption, distribution, metabolism or excretion of drugs within 48 hours prior to admission; 14. Those who have special dietary requirements and cannot accept a uniform diet; 15. Female subjects who are pregnant or breastfeeding during the trial; 16. Vital signs examination, physical examination, clinical laboratory examination, 12-lead electrocardiogram, abdominal ultrasound, urological ultrasound, orthopantomogram, etc. showing abnormalities with clinical significance; 17. Those deemed by the investigator to be unsuitable for clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma drug concentration;Urine drug concentration;Adverse events;Vital signs;Laboratory examination;Routine 12-leads electrocardiogram; | — |
Countries
China
Contacts
Public ContactHui Zhao, Wei Hu
Outcome results
None listed