NCT00822341已完成1 期
A Randomized, Double-Blind, Placebo-Controlled, Sequential Ascending Single Intravenous Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TG-0054 in Healthy Subjects
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- To assess the safety and tolerability for a single IV dose of TG-0054
研究概览
简要总结
TG-0054 is a CXCR4 antagonist with stem cell mobilization effect as proven in animal model, this is the fist in human study to investigator the safety, tolerability and PK/PD in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female 18 to 45 years of age inclusive
- •Body mass index (BMI) in the range of 19.0 to 30.0 kg/m² and body weight ≥ 50 kg inclusive
- •Good physical and mental health status determined on the basis of the medical history and a general clinical examination
- •Subjects must have used a consistent form of acceptable oral birth control or the double barrier method (intrauterine device (IUD) plus condom, spermicidal gel plus condom) for at least 3 months prior to study initiation
排除标准
- •Any medical condition (other than a self-limited illness) that requires ongoing and current medical attention
- •History of any other hematologic disorders including thromboembolic disease or anemia
- •Severe trauma, fracture, major surgery, or biopsy of a parenchymal organ within the past 3 months
- •Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
- •Subjects who currently smoke (intake nicotine or nicotine-containing products) or have given up smoking for less than 6 months before the first administration of study drug
- •Subjects who are carriers of the Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody or who are Human Immunodeficiency Virus (HIV) antibody positive
结局指标
主要结局
To assess the safety and tolerability for a single IV dose of TG-0054
To determine the maximum tolerated dose (MTD) of TG-0054
次要结局
- To assess the plasma pharmacokinetics (PK) profile of TG-0054
- To assess the pharmacodynamic (PD) effects of TG-0054 via CD34+stem cell, CD133+ progenitor cell counts; white blood cell (WBC), red blood cell (RBC), platelet, and differential counts
研究者
研究点 (2)
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