NCT01548391Unknown1 期
A Phase I Clinical Study Study of the Safety, Tolerability, and Pharmacokinetics of HX-1171 in Healthy Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Safety (normal results for safety tests)
研究概览
简要总结
This study is designed to evaluate the safety, tolerability, and pharmacokinetics of HX-1171 in healthy male 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
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Adult males aged 20 to 40 years at screening.
- •Be able to comply with the requirement of the study. Subject must provide written informed consent prior to study participation.
排除标准
- •History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or gastrointestinal disorders.
- •History of known hypersensitivity to drugs including HX-1171.
研究组 & 干预措施
HX-1171 20 mg (20mg 1T)
Experimental
干预措施: HX-1171 (Drug)
HX-1171 80 mg (20mg 4T)
Experimental
干预措施: HX-1171 (Drug)
HX-1171 40 mg (20mg 2T)
Experimental
干预措施: HX-1171 (Drug)
HX-1171 160 mg (20mg 8T)
Experimental
干预措施: HX-1171 (Drug)
HX-1171 300 mg (200mg 1T, 20mg 5T)
Experimental
干预措施: HX-1171 (Drug)
HX-1171 600 mg (200mg 3T)
Experimental
干预措施: HX-1171 (Drug)
HX-1171 1200 mg (500mg 2T, 200mg 1T)
Experimental
干预措施: HX-1171 (Drug)
HX-1171 1500 mg (500mg 3T)
Experimental
干预措施: HX-1171 (Drug)
HX-1171 2000 mg (500mg 4T)
Experimental
干预措施: HX-1171 (Drug)
结局指标
主要结局
Safety (normal results for safety tests)
时间窗: 14days
Physical examination, Vital signs
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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