Pharmacokinetics, Safety and Tolerability of Single Infusion of Amphotericin B Colloidal Dispersion In Healthy Subjects in China
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of single infusion of ABCD
研究概览
简要总结
The purpose of this trial is to evaluate the pharmacokinetics of single intravenous of Amphotericin B Colloidal Dispersion(ABCD)in Chinese healthy subjects.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) of 19 to 26 kg/m2, inclusive 19 and
- •BMI = weight (kg)/[height(m)]
- •Subjects are fully informed and voluntarily consent to participate in this study.
排除标准
- •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.
研究组 & 干预措施
ABCD
Group1: 0.5mg/kg Group2: 1.0mg/kg Group3: 1.5mg/kg
干预措施: ABCD (Drug)
结局指标
主要结局
Pharmacokinetics of single infusion of ABCD
时间窗: 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
Area under the plasma concentration versus time curve
次要结局
未报告次要终点