Empirical treatment of suspected fungal infections in febrile neutropenia patients
Conditions
Interventions
Test Drug:Amphotericin B liposomes for injection, 2.0 mg/kg
Reference Listed Drug:Liposome for Injection,2.0 mg/kg
Sponsors
Phase I Clinical Trial Department, The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1)Able and willing to give written informed consent before study, and fully understand the study content, process and possible adverse reactions; 2 )Able to complete the study in compliance with the protocol; 3 )Subjects (including subjects partner) agree to adopt effective contraceptive measurements(Appendix 4) and not plan a pregnancy from 2 weeks before the first dosing to 6 months after the last dosing of reference or test formulation; 4) Male and non-pregnant, non-lactating female subjects between the ages of 18 and 55 years,inclusive; 5 )At least 50 kg for male subjects, 45 kg for female subjects and both no more than 80 kg (with boundary value),with a Body Mass Index (BMI= Weight/Height2) between 18-28 kg/m2,)inclusive; 6) With normal or clinically insignificant abnormal results of physical examination and vital signs test, in which the acceptable reference range for systolic blood pressure is from 101 to 139 mmHg and for diastolic blood pressure the range is from 70 to 89 mmHg
Exclusion criteria
Exclusion criteria: 1)More than 5 cigarettes per day within 3 months before the study; 2)History of sensitivity to any components of Liposomal Amphotericin B, allergic constitution(e.g. allergy to various drugs and foods); 3)History of alcohol abuse (14 units of alcohol per week: 1 units = 285 mL beer, 25 mL spiritor 100 mL wines); 4)Donation or loss of a significant volume of blood (> 450 mL) within 3 months prior toscreening; 5)Intake of any drug which may affect liver drug enzyme activity within 28 days prior to screening, any CYP3A4, P-gp and Bcrp inducers or inhibitors (e.g. Itraconazole,Ketoconazole or Dronedarone, etc.); 6)Intake of any prescription drugs, over-the-counter drugs, vitamin or herbal medicine within 14 days prior to screening; 7)Consumption of any special diet (such as pitaya, mango, pomelo, grapefruit etc.) or subjects have engaged strenuous exercise or any other factors affecting drug absorption, distribution,metabolism and excretion within 2 weeks prior to screening; 8)Recent major changes in diet or exercise habits; 9)Use of an investigational drug or product, or participation in a drug research study within 3 months prior to receiving study drug; 10)Suffering from any diseases that may increase the risk of bleeding, such as hemorrhoids,acute gastritis, or stomach and duodenal ulcers, etc.; 11)A clinically significant ECG abnormality; 12)Positive test results of pregnancy or subject is lactating during screening or study period for female subjects; 13)The level of AST or ALT, total bilirubin or direct bilirubin, alkaline phosphatase and creatinine are higher than the upper limit of normal, and serum potassium is lower than the lower limit of normal; 14)Any clinically significant abnormalities/findings in laboratory tests, or any clinically significant disease 12 months before screening including but not limited to gastrointestinal,renal, hepatic, neurological system, blood, endocrine, tumor, lung, immune, mental, or cardiovascular and cerebrovascular diseases; 15)Positive test results for viral hepatitis (including hepatitis B and C), HIV antibody or syphilis antibody; 16)Acute illness or concomitant medication from screening to the first dosing of study medication; 17)Consumption of chocolate or any food or beverages containing caffeine or rich in xanthine within 24 h prior to receiving the first dosing of study medication; 18)Consumption of any product containing alcohol within 24 h prior to receiving the first dosingof study medication, or positive results from a screen for alcohol; 19)Positive results from a screening for urine drug test or a history of drug abuse in the past 5years; 20). Any condition which in the opinion of Investigator is not suitable for subjects to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, AUC0-t; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax, AUC_%Extrap, t1/2, ?z of liposome-encapsulated amphotericin B and free amphotericin B if data permit; | — |
Countries
China
Contacts
Public ContactYanhua Ding
Outcome results
None listed