NCT00916110已完成1 期
Ascending Single Dose Study Of The Safety, Tolerability, PK And PD Of ATN-103 Administered SC Or IV To Healthy Japanese Male Subjects
Ablynx, a Sanofi company1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2008年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Safety and tolerability are evaluated from the reported AEs, vital sign, laboratory test, etc.
研究概览
简要总结
To assess the safety and tolerability of ascending single SC and IV doses of ATN-103 in healthy Japanese male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy Japanese male subjects aged 20 to 45 with health determined by the study investigator.
- •BMI in the range of 17.6 to 26.
- •Nonsmoker or male who smokes fewer than 10 cigarettes per day.
排除标准
- •Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
- •Acute disease state (eg, nausea, vomiting, infection, fever, or diarrhea) within 7 days before study day 1.
研究组 & 干预措施
1.5mgSC
Experimental
ATN-103
干预措施: ATN-103 (Drug)
4mgSC
Experimental
ATN-103
干预措施: ATN-103 (Drug)
10mgSC
Experimental
ATN-103
干预措施: ATN-103 (Drug)
25mgSC
Experimental
ATN-103
干预措施: ATN-103 (Drug)
25mgIV
Experimental
ATN-103
干预措施: ATN-103 (Drug)
50mgSC
Experimental
ATN-103
干预措施: ATN-103 (Drug)
100mgSC
Experimental
ATN-103
干预措施: ATN-103 (Drug)
200mgSC
Experimental
ATN-103
干预措施: ATN-103 (Drug)
200mgIV
Experimental
ATN-103
干预措施: ATN-103 (Drug)
结局指标
主要结局
Safety and tolerability are evaluated from the reported AEs, vital sign, laboratory test, etc.
时间窗: 24weeks
次要结局
- Antibody in blood and drug concentration in blood and urine are evaluated.(24weeks)
研究者
研究点 (1)
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