NCT01637285已完成1 期
A Phase 1, Randomized, Open-label, Parallel-group Study To Evaluate The Pharmacokinetics Of Pf-04856883 (Cvx-096) Following Subcutaneous Administration In Healthy Volunteers
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- PF-04856883 Pharmacokinetics including Cmax, Tmax, AUCo-infinity, AUClast, Cl/F, Vz/F and t1/2
研究概览
简要总结
The purpose of the study is to further evaluate the PK characteristics of PF-04856883.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
PF-04856883 Treatment Arm 4
Experimental
干预措施: PF-04856883 (Biological)
PF-04856883 Treatment Arm 1
Experimental
干预措施: PF-04856883 (Biological)
PF-04856883 Treatment Arm 2
Experimental
干预措施: PF-04856883 (Biological)
PF-04856883 Treatment Arm 3
Experimental
干预措施: PF-04856883 (Biological)
结局指标
主要结局
PF-04856883 Pharmacokinetics including Cmax, Tmax, AUCo-infinity, AUClast, Cl/F, Vz/F and t1/2
时间窗: 4 weeks
次要结局
- Number of subjects with abnormal clinical laboratory results(4 weeks)
- Number of subjects with abnormal ECGs(4 weeks)
- Number of subjects with abnormal vital signs(4 weeks)
- Number of subjects with AEs reported(4 weeks)
- Number of subjects with abnormal physical examination findings(4 weeks)
研究者
研究点 (2)
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