NCT00991159已完成1 期
A Phase 1, Placebo-Controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Single, Escalating, Intravenous Doses Of RN316 (PF-04950615) In Healthy Adult Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 48
- 试验地点
- 3
- 主要终点
- Safety and tolerability of single, escalating, intravenous infusions of RN316 administered to healthy adult subjects
研究概览
简要总结
The study is designed to determine the safety and tolerability of RN316 when administered intravenously to healthy adult subjects. This is the first time RN316 has been given to humans.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, ambulatory men and women (of non-childbearing potential) ages 18 -70 inclusive.
- •Baseline total cholesterol ≥ 200 mg/dl, baseline LDL ≥ 130 mg/dl.
- •BMI 18.5 to 35, and body weight ≤150 kg, inclusive.
排除标准
- •Evidence of clinically significant disease that may increase the risk to the subject of study participation or interfere with interpretation of results.
- •Secondary hyperlipidemia.
- •Subjects who have taken lipid lowering compounds within the past 12 months prior to dosing.
结局指标
主要结局
Safety and tolerability of single, escalating, intravenous infusions of RN316 administered to healthy adult subjects
时间窗: Entire duration of study
次要结局
- pharmacokinetics of RN316 in plasma after administration of single, escalating, intravenous infusions of RN316 to healthy adult subjects(Entire duration of study)
- pharmacodynamic effect (lipid-lowering) of single, escalating, intravenous doses of RN316 administered to healthy adult subjects(Entire duration of study)
- single dose immunogenicity(Entire duration of study)
研究者
研究点 (3)
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