Complicated urinary tract infections, hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, and treatment of infections caused by aerobic gram-negative bacteria
Conditions
Interventions
Cefiderocol Group:Cefiderocol for Injection
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Male or female (male:female=1:1) subjects aged from 18 to 45 years inclusive, at the time of signing the informed consent form. 2. Subjects with body weight of = 50.0 kg for male and = 45.0 kg for female, and body mass index (BMI) of = 19 and < 26 kg/m2. 3. Subjects who have no pregnancy plan and voluntarily take effective contraceptive measures and have no sperm or egg donation plan from the study period to 3 months after the last administration for specific contraceptive measures; Female subjects should be non-lactating, have a negative pregnancy test, or be not considered WOCBP. 4. Subjects who are able to understand the study and comply with all study procedures, and willing to provide written informed consent prior to screening.
Exclusion criteria
Exclusion criteria: 1. Subjects with a history of hypersensitivity attributed to ß-lactam antibiotics (including cephalosporin carbapenem or penicillin antibiotics), or any drugs or food, or with any previous or existing allergic symptoms (including sensitivity to iodine, sensitivity to poison ivy or other catechol-related hypersensitivity, food allergies, but with the exception of currently asymptomatic allergic rhinitis). 2. Subjects with any previous or existing cardiovascular, respiratory, liver, kidney, gastrointestinal, endocrine, blood, or nervous system diseases. Examples of excluded conditions include but are not limited to: hypertension, angina, heart failure, asthma, hepatitis, cirrhosi, kidney damage, gastric ulcer, diabetes, anemia, epilepsy, schizophrenia, malignant tumors, etc. 3. Subjects with recurrent diarrhea and headache. 4. Subjects with physical examination results of clinical significant and with the following laboratory test values at admission: • Aspartate aminotransferase (AST) > upper limit of normal (ULN) • Alanine aminotransferase (ALT) > 1.5×ULN • Alkaline phosphatase (ALP) > ULN • Total bilirubin > 1.5×ULN • Creatinine clearance = 80 mL/min as calculated from • serum creatinine by Cockcroft-Gault formula 5. Subjects with abnormal clinically significant results of ECG, physical examination, vital signs, and laboratory test. 6. Subjects with a history of heart disease which is considered clinically significant by the investigator, or QTc interval > 450 msec. 7. Subjects with a resting systolic blood pressure > 140 or 90 or 100 or 37.5? or < 35?. 9. Female subjects who have a positive blood pregnancy test. 10. Subjects who require any chronic drug therapies or who have been exposed to any drugs (eg, prescription drugs, over-the-counter drugs, Chinese herbal medicines, and other supplements/vitamin preparations) within 14 days prior to admission. 11. Subjects who smoked or consumed any nicotine-containing products from 24 weeks prior to the initial screening visit to admission. 12. Subjects with a history of alcohol (drinking more than 14 units of alcohol per week in the 6 months before screening (1 unit of alcohol = 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine) or taking alcohol 48 hours before administration, or those who have a positive alcohol breath test during the screening period and/or baseline period.). 13. Subjects with a positive result for urine screening test for drug abuse. 14. Subjects who have positive test results for serologic test for treponema pallidum particle agglutination (TPPA), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody. 15.Subjects with a history of blood donation or blood loss of more than 400 mL in 3 months prior to screening, or subjects who received blood transfusion within 8 weeks. 16. Subjects who have participated in other drug clinical studies within 3 months prior to initiation of administration. 17. Subjects who have received vaccination within 4 weeks before screening, or plan to be vaccinated during the study period. 18. Subjects with other situations that considered inappropriate for the study by the investigator. 19. Subjects who have participated in cefiderocol (S-649266) trials and have received the study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Single dose:Maximum plasma concentration (Cmax);Single dose:time to maximum plasma concentration (Tmax);Single dose: area under the concentration-time curve from time zero to the time of the last quantifiable concentration after dosing (AUC0-last);Single dose: area under the concentration-time curve extrapolated from time zero to infinity (AUC0-inf);Single dose: area under the concentration-time curve over the dosing interval (8 hours) (AUC0-8);Single dose: terminal elimination half-life (t1/2,z);Single dose:mean residence time (MRT);Single dose: terminal elimination rate (?z);Single dose: total clearance (CL);Single dose: volume of distribution (Vz);Multiple dose: Time to maximum plasma concentration (Tmax);Multiple dose:area under the concentration-time curve over the dosing interval t (8 hours) (AUC0-t);Multiple dose: terminal elimination half-life (t1/2,z);Multiple dose: terminal elimination rate constant (?z);Multiple dose: total clearance (CL);Multiple dose: maximum plasma concentration at steady state (Cmax,ss);Multiple dose: trough plasma concentration at steady state (Cmin,ss);Multiple dose: average plasma concentration at steady state (Cavg,ss);Multiple dose: accumulation ratio of AUC (Rac (AUC));Multiple dose: accumulation ratio of Cmax (Rac (Cmax));Multiple dose: fluctuation ratio (DF); | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety; | — |
Countries
China
Contacts
Public ContactJing Zhang
Huashan Hospital, Fudan University
Outcome results
None listed