NCT00822484已完成1 期
Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ILV-095 Administered Subcutaneously to Healthy Japanese Male Subjects
Wyeth is now a wholly owned subsidiary of Pfizer1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2009年2月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Safety and tolerability will be evaluated from the reported AEs including any injection-site reactions, physical examinations, vital sign measurements, cardiac rhythm monitoring, 12-lead ECGs, and clinical laboratory test results.
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of single doses of ILV-095 in healthy Japanese 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
- 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
- •Men aged 20 to 45 years inclusive at screening. Sexually active men must agree to use a medically acceptable form of contraception during the study and continue it for 12 weeks after study drug administration.
- •Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight greater than or equal to 45 kg.
- •Healthy as determined by the investigator on the basis of screening evaluations.
- •Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.
- •Have a high probability for compliance with and completion of the study.
排除标准
- •Presence or history of any disorder that may prevent the successful completion of the study.
- •Any subject who had orthopedic surgery within 12 weeks of the screening visit or has planned (elective) orthopedic surgery within 12 weeks of study drug administration.
- •Acute disease state (eg, nausea, vomiting, infection, fever, active infection, or diarrhea) within 7 days before enrollment.
结局指标
主要结局
Safety and tolerability will be evaluated from the reported AEs including any injection-site reactions, physical examinations, vital sign measurements, cardiac rhythm monitoring, 12-lead ECGs, and clinical laboratory test results.
时间窗: 3 weeks per group
次要结局
- Pharmacokinetic parameters(3 weeks per group)
研究者
研究点 (1)
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