Pharmacokinetics and Safety of AmBisome and DKF-5122

Inclusion criteria

• Part 1. Patients

• Age 19 years and older
• Empirical therapy for presumed fungal infection in febrile, neutropenic patients
• Voluntarily decided to participate in the study and signed the informed consent form
• Having contraception during the study
• Part 2. Healthy subjects

• Age 19 to 45 years
• Body weight 55 kg or more, within ±20% of the ideal body weight
• Having no congenital or chronic disease within the last 5 years.
• Voluntarily decided to participate in the study and signed the informed consent form
• Having contraception during the study

Exclusion criteria

• Part 1. Patients

• Clinically significant conditions that may affect the pharmacokinetics of amphotericin
• History of diseases that may affect the pharmacokinetics of amphotericin
• History of drug abuse
• History of hypersensitivity to ingredients of investigational products
• Unable to maintain proper contraception
• Pregnant or breast-feeding
• The following laboratory test results at screening

• Hemoglobin < 8.0 g/dL
• Serum Creatinine > 2x the UNL
• AST or ALT > 10x UNL
• Systolic blood pressure ≥ 140 mmHg or ≤ 90 mmHg
• Diastolic blood pressure ≥ 90 mmHg or ≤ 60 mmHg
• Before the first administration of investigational products

• Participation to other clinical trials within 6 months
• Whole blood donation within 60 days or component within 30 days
• (Herbal) medicines that may affect the pharmacokinetics of amphotericin within 14 days
• Grapefruit-containing foods within 7 days
• Excessive exercise within 7 days
• Excessive caffeine and alcohol consumption, or a smoker
• Not eligible due to other reasons at the investigator's discretion
• Part 2. Healthy subjects

• Clinically significant disorders or a medical history of active cardiovascular, respiratory , kidney, endocrine, hematological, digestive, central nervous system, psychiatric disease, or malignant tumor
• Clinically significant conditions that may affect the pharmacokinetics of amphotericin
• History of diseases that may affect the pharmacokinetics of amphotericin
• History of drug abuse
• History of hypersensitivity to ingredients of investigational products
• Unable to maintain proper contraception
• Pregnant or breast-feeding
• The following laboratory test results at screening

• Hemoglobin < 13.0 g/dL
• Serum Creatinine > 1.25 x UNL
• eGFR < 90 mL/min/1.73 m2
• AST or ALT > 1.25 x UNL
• Total bilirubin > 1.25 x UNL
• CPK > 1.5 x UNL
• Systolic blood pressure ≥140 mmHg or ≤90 mmHg
• Diastolic blood pressure ≥ 90 mmHg or ≤60 mmHg
• Arrhythmia
• Before the first administration of investigational products

• Participation to other clinical trials within 6 months
• Whole blood donation within 60 days or component within 30 days
• Drugs that induce or inhibit drug metabolism enzymes within 30 days
• Vaccination within 7 days
• Prescription drugs, herbal medicines, over-the-counters, or vitamins within 14 days
• Grapefruit-containing foods within 7 days
• Excessive exercise within 7 days
• Excessive caffeine and alcohol consumption, or a smoker
• Not eligible due to other reasons at the investigator's discretion