Single Dose Escalations Study of Amphotericin B Colloidal Dispersion In Healthy Subjects in China

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pharmacokinetics, Safety and Tolerability of Single Infusion of Amphotericin B Colloidal Dispersion In Healthy Subjects in China

Conditions
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Invasive Fungal Disease

Intervention / Treatment
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* Drug: ABCD


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABCD<br>Group1: 0.5mg/kg Group2: 1.0mg/kg Group3: 1.5mg/kg | Drug: ABCD<br>* Intravenous infusion of dexamethasone 5mg before ABCD intravenous administration; Single infusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of single infusion of ABCD | Peak Plasma Concentration,. | 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 | 
| Pharmacokinetics of single infusion of ABCD | Area under the plasma concentration versus time curve | 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 |