A Phase 1, Randomized, Double Blind (Sponsor Open), Placebo Controlled, Single-Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effect of PF-04629991 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Pharmacokinetics e.g., maximum concentration and area under the concentration-time curve
研究概览
简要总结
This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-04629991 in healthy subjects. Dose exploration will proceed in a step-wise manner, beginning with low doses not expected to have significant biological effects and proceeding to doses approximating or exceeding the anticipated therapeutic level. Doses to be explored may be limited by tolerability, and will not exceed levels previously shown to be tolerable in animals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy non-smoking men and women
- •body mass index 18-30 kg/m2
排除标准
- •Women must not be able to have children
- •no current infections
研究组 & 干预措施
first of three dosing cohorts
干预措施: PF-04629991 (Drug)
second of three dosing cohorts
干预措施: PF-04629991 (Drug)
third of three dosing cohorts
干预措施: PF-04629991 (Drug)
结局指标
主要结局
Pharmacokinetics e.g., maximum concentration and area under the concentration-time curve
时间窗: 2 weeks
Safety/Tolerability e.g., reported adverse events and safety laboratory studies
时间窗: 2 weeks
Pharmacodynamics e.g., changes in a peripheral blood biomarker
时间窗: 2 weeks
次要结局
未报告次要终点