None
Conditions
Interventions
Low dose group:intravenous infusion polymyxin sulfate B 0.75 mg/kg
Middle dose group:intravenous infusion polymyxin sulfate B 1.5 mg/kg
High dose group (2.5 mg/kg):intravenous infusion polymyxin sulfate B 2.5 mg/kg
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
19 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Aged 19 and 45 years old; 2. weight requirement: female 45 kg, male 50 kg. Body mass index (BMI) ranged from 19 to 26 kg/ m2 (including 19 and 26), and body mass index = weight (kg)/[height (m)]2; 3. patients with normal or abnormal medical history, physical examination, vital signs, 12-lead electrocardiogram and laboratory examination without clinical significance during screening; 4. female subjects of reproductive age shall meet the following conditions: (1) Blood pregnancy response was negative at baseline; (2) agree to use one of the approved methods of contraception (e.g., oral contraceptives, spermicide and condoms, or intrauterine devices) throughout the study period. They also agree that the method of contraception used will remain the same throughout the study period; (3) non-lactation. 5. male subjects of child-bearing age agree to use reliable contraceptive measures (such as condoms or partners using the above four measures) during the study period; 6. voluntarily sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) people who are known to have allergies to polymyxin B sulfate, or who are known to have anaphylactic shock or other severe allergic reactions to -lactamide antibiotics such as penicillin, cephalosporins and carbapenems (such as epidermolysis of bullosa and dermatitis exfolians); (2) people with allergies, including those allergic to food and other drugs; (3) have a history of heparin allergy or heparin-induced thrombocytopenia; (4) have a clear history of chronic cardiovascular disease, liver, kidney, lung, blood, endocrine, digestive tract, metabolism, skeletal muscle system and bone marrow suppression; (5) have a history of epileptic seizures or convulsions; (6) screening, ear temperature > 37.5 ?, breathing 20 times/min, oximetry 99 times/min, systolic blood pressure 140 MMHG, diastolic blood pressure 90 MMHG. (7) abnormal 12-lead ecg examination with clinical significance, including arrhythmia and obvious QT abnormalities (QTcF interval? 450 msec); (8) the results of laboratory examination exceed the reference value and have clinical significance determined by the researcher; (9) in the screening of human immunodeficiency virus antibody (HIVAb), syphilis antibody (TPPA), hepatitis b antigen (HBsAg) or hepatitis c antibody (HCVAb) virus serum immunological test items, one of which is positive; (10) endogenous creatinine clearance CrCL < 90ml/min, endogenous creatinine clearance formula was CrCL=[(140- age) body weight (kg)]/[0.818 Scr(mol/L)], female calculated results 0.85. Note: CrCL (endogenous creatinine clearance), Scr (serum creatinine); (11) drug abusers/prohibited drugs, positive drug screening in urine at the time of screening or 1 day before drug administration; (12) alcoholics, positive screening by alcohol breath test at the time of screening or 1 day before drug administration; (13) blood donation or blood loss 400 mL within 3 months before entering this clinical trial; (14) those who were not allowed to smoke and drink alcohol, caffeine and juice drinks 72h before the start of the clinical study and 72h before the end of the study; (15) direct stakeholders involved in this clinical study; (16) 6. did not take drugs that are known to damage certain organs within 3 months before entering this clinical trial; (17) participate in the clinical study of other drugs within 3 months before entering this clinical trial; (18) take any medicine (including traditional Chinese medicine and non-prescription drugs) within 2 weeks before entering this clinical trial; (19) the investigator judges that other conditions are not suitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Abnormal adverse events;Adverse reaction;Vital signs;12 lead electrocardiogram;Laboratory examination;Plasma concentration of polymyxin B;Urine concentration of polymyxin B; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cmax;Tmax;T1/2;AUC0-12;AUC0-inf;Vd;CLt;MRT;?Z; | — |
Countries
China
Contacts
Public ContactZhang Jing
Huashan Hospital, Fudan University
Outcome results
None listed