Invasive Fungal Disease
Conditions
Brief summary
The purpose of this trial is to evaluate the pharmacokinetics of single intravenous of Amphotericin B Colloidal Dispersion(ABCD)in Chinese healthy subjects.
Detailed description
Primary Objective: Evaluation the pharmacokinetics, safety and tolerability of single intravenous of ABCD in Chinese healthy subjects. Secondary Objective: Evaluation the safety and tolerability of single intravenous of ABCD in Chinese healthy subjects. Exploratory Objective:Evaluation the effect of single intravenous ABCD on early renal injury indicators (KIM-1 and cystatin C) in Chinese healthy subjects.
Interventions
DRUGABCD
Intravenous infusion of dexamethasone 5mg before ABCD intravenous administration; Single infusion.
Sponsors
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Study design
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index (BMI) of 19 to 26 kg/m2, inclusive 19 and 26. BMI = weight (kg)/\[height(m)\]2. * Subjects are fully informed and voluntarily consent to participate in this study.
Exclusion criteria
* History of allergy or hypersensitivity. * Presence of any acute or chronic medical condition within 3 months prior to investigational products administration, including but not limited to: hepatic, gastrointestinal, renal, hematologic (including coagulation), pulmonary, neurologic, respiratory, endocrine, or cardiovascular system abnormalities; psychiatrical disease including major psychiatric disorders (e.g., schizophrenia, bipolar disorder); acute infection; or other conditions that would interfere with the absorption, distribution, metabolism, or excretion of drugs. * During the screening period, abnormal and clinically significant of physical examination, vital signs, laboratory examination, etc. * A positive result in hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), anti-hepatitis C virus (HCV) antibodies, a syphilis test, or an human immunodeficiency virus (HIV) test. * Lost blood or donated more than 400 mL of blood within 3 months prior to the screening. * Participation in a clinical drug study 30 days prior to present study. * Use of any other drugs within 2 weeks prior to the screening. * Subjects planning to give birth or donate sperm during the study or within 3 months after the study. * The partner of the subject is unwilling to take effective contraceptive measures. * Other unfavorable factors diagnosed by investigators.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of single infusion of ABCD | before infusion and at the midpoint and end of the infusion;and at 15 and 30 min;1,2,4,7,10,24,48,72,120,168,240,336,408,504,576 and 672hour postinfusion | Peak Plasma Concentration,. |
Countries
China
Outcome results
None listed