aerobic gram-negative bacterial infections in adults
Conditions
Interventions
Experimental group1:1g Nacubactam for injection/250 mL 0.9% sodium chloride injection
Experimental group2:2g Nacubactam for injection/250 mL 0.9% sodium chloride injection
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1.Healthy male subjects aged 18-45 years (inclusive); 2.Body weight >= 50 kg, body mass index (BMI) = weight (kg)/(height)^2 (m^2), BMI between 19.0 and 28.0 kg/m^2 (inclusive); 3.Subjects who do not plan to have children and agree to use non-hormonal contraceptive measures during the study and six months after the completion of the study; 4.Subjects who understand the study procedures and methods, voluntarily participate in this study and sign an informed consent in person.
Exclusion criteria
Exclusion criteria: 1. Subjects with clinically significant past or present medical conditions such as circulatory, endocrine, nervous, digestive, respiratory, genitourinary system, hematological, immunological, psychiatric, or metabolic abnormalities, or any other conditions that may interfere with the study results and not suitable to participate in the study at the discretion of the investigator; 2. Subjects with abnormal and clinically significant vital signs (body temperature, respiration, pulse rate, blood pressure), physical examination (general conditions, head and neck, lymph nodes, chest, abdominal, spine, and limbs) and laboratory tests (blood routine, urine routine, coagulation function, blood chemistry, virological screening, etc.); subjects with abnormal and clinically significant 12-lead ECG and chest x-ray and not suitable for the study at the discretion of the investigator. 3. Subjects with a history of alcohol abuse or regular alcohol consumption within 6 months prior to the trial, i.e., those who consume more than 14 units of alcohol per week (1 unit = 360 ml of beer or 45 ml of spirits at 40% alcohol or 150 ml of wine) or those who cannot stop using any alcohol-containing product during the trial; 4. Subjects with a history of heavy smoking (more than 5 cigarettes a day within 3 months prior to the trial), not able to stop using any tobacco products during the trial or with a history of drug abuse; 5. Subjects who may be allergic to the investigational product or any ingredient in the investigational product or unable to use ß-lactam agents at the discretion of the investigator; 6. Subjects with a known history of clinically significant allergies or urticaria, or a history of severe allergic reactions to any medication, especially antibiotics; 7. Subjects who have had any surgery within 6 months before screening; 8. Estimated glomerular filtration rate (eGFR) 450 msec (Fridericia’s formula: QTcF = QT/(RR^0.33)); 10. Subjects who have positive test results for any of the viral screening tests (hepatitis B surface antigen, hepatitis C virus antibody test, human immunodeficiency virus antigen/antibody initial screening, treponema pallidum antibody). 11. Subjects who have donated blood, experienced significant blood loss (>=200 ml), received blood transfusion or used blood products within the 3 months prior to screening. 12. Subjects who have participated in clinical studies of other drugs or medical devices within 3 months before screening; 13. Subjects with epilepsy (or a known seizure disorder), brain injury or other significant neurological diseases; 14. Subjects who have had any acute illness determined by the investigator to be clinically significant within 1 month before screening; 15. Subjects with a medication history (including vaccines) within 4 weeks before screening, and not suitable for the study at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK paremaeters;tolerability; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety ; | — |
Countries
China
Contacts
Public ContactGuoping Yang
The Third Xiangya Hospital of Central South University
Outcome results
None listed