healthy subjects
Conditions
Interventions
SAD stage IMBZ18g group:Six dose groups (100mg,250mg,500mg,1000mg,2000mg and 3000mg) will perform intravenous infusion of administration on an empty stomach.
SAD stage placebo group:Five dose groups (250mg,500mg,1000mg,2000mg and 3000mg) will perform intravenous infusion of physiological saline on an empty stomach.solution
MAD stage IMBZ18g group:There dose groups (500mg,1000mg and 2000mg ) will perform intravenous infusion of administration on an empty stomach.
MAD stage placebo group:There dose groups (500mg,1000mg and 2000mg ) will perform intravenous infusion of physiological saline on an empty stomach.solution
Sponsors
The Third Hospital of Changsha
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be included in the study: 1. Chinese volunteers aged 18 to 45 years old (inclusive), both male and female; 2. The weight of male volunteers should not be less than 50 kg, and the weight of female volunteers should not be less than 45 kg; the body mass index should be within the range of 19-26 (including the critical value). Body Mass Index (BMI)=Weight (kg)/Height ^2 (m ^2) ; 3. Sign the informed consent form before the trial and fully understand the trial content, process and possible adverse reactions; 4. Volunteers are able to communicate effectively with researchers and understand and comply with the requirements of this study.
Exclusion criteria
Exclusion criteria: If a subject meets any of the following criteria, they will be excluded from the study: 1.Individuals who have participated in any clinical trial of the investigational drug within the past 3 months and have used the investigational drug; 2.Individuals with a history of respiratory system, cardiovascular system, endocrine system, urinary system, nervous system, hematology, immunology (including personal or family history of hereditary immunodeficiency), metabolic abnormalities, etc., who are still clinically significant according to the researchers; 3.Individuals who are allergic to penicillin and cephalosporins, or to any component of this drug, or have a history of allergies to drugs, food, or other substances, or have an allergic constitution; 4.Individuals with liver or kidney diseases, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs, or with sequelae of these diseases; 5.Individuals with Clostridium difficile associated diarrhea; 6.Individuals who have used any drugs that affect the absorption and metabolism of the investigational drug within 30 days prior to its use, and have been deemed unsuitable by the researcher to participate in the trial; 7.Individuals who have used any medication (including traditional Chinese herbs, health supplements, etc.) within the 14 days prior to using the research drug; 8.Those who have undergone surgery that the researcher judged would affect drug absorption, distribution, metabolism, and excretion within 6 months before using the study drug; or those who have undergone surgery within 4 weeks before using the study drug; or those who plan to undergo surgery during the trial; 9.Creatinine clearance calculated according to the Cockcroft-Gault formula at screening = 80 mL/min; 10.Those with clinically significant abnormalities in physical examination, electrocardiogram, vital signs, laboratory tests (four blood transfusions, blood biochemistry, blood routine, coagulation function, urine routine) (subject to the judgment of clinical physicians); 11.Those who donated blood or lost a large amount of blood (>400 mL) within 3 months before using the study drug, received blood transfusion or used blood products, or planned to donate blood or blood components during the trial or within 3 months after the end of the trial; 12.Alcoholics or regular drinkers within 6 months before using the study drug, that is, drinking more than 14 units of alcohol per week (1 unit = 360 mL beer or 45 mL of 40% alcohol liquor or 150 mL wine); or unwilling to stop drinking or any alcoholic products during the trial; 13.Drug abusers or those who have used soft drugs (such as marijuana) or hard drugs (such as cocaine, phencyclidine, etc.) within 1 year before using the study drug; 14.Smokers or those who smoke more than 5 cigarettes a day in the 3 months before using the study drug, or cannot stop using any tobacco products during the trial; 15.Those who drink excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) every day, or those who do not agree to stop drinking tea, coffee and/or caffeinated beverages during the trial; 16.Those who have consumed food that may affect the metabolism of the drug in the body (including grapefruit or grapefruit products, pitaya, mango, pomelo, orange, etc.) within 7 days before the use of the study drug, or those who the researchers believe have other foods that affect the absorption, distributi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events;Laboratory evaluation (blood routine, blood biochemistry, urine routine, coagulation function);12 lead electrocardiogram (ECG); Vital signs;Physical examination; Injection site reaction; | — |
Secondary
| Measure | Time frame |
|---|---|
| Single dose PK parameters;multiple dose PK parameters; | — |
Countries
China
Contacts
Public ContactLi Xin
The Third Hospital of Changsha
Outcome results
None listed