Phase I Pharmacokinetics And Tolerability Of PF-04236921 Following Subcutaneous Administration To Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Incidence and severity of adverse events
研究概览
简要总结
This study will evaluate the safety, tolerability, and pharmacokinetics of PF-04236921 administered as a single subcutaneous dose in healthy volunteers.
详细描述
Tolerability and Pharmacokinetics of subcutaneously administered dose of PF-04236921 in healthy volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Healthy males between 18-55 years, inclusive.
- •Healthy females of non-childbearing potential between 18 and 55 years, inclusive.
排除标准
- •Evidence or history of clinically significant disease.
- •Females of childbearing potential.
研究组 & 干预措施
1
干预措施: PF-04236921 (Drug)
结局指标
主要结局
Incidence and severity of adverse events
时间窗: 5 months
Incidence and severity of clinical findings on physical examination
时间窗: 5 months
Mean change from baseline in vital signs (blood pressure, pulse rate, oral or tympanic temperature) measurements
时间窗: 5 months
Mean change from baseline in 12-lead electrocardiogram (ECG) parameters: PRI, RR, QRS, QT, QTcF (Freidericia's correction) and HR (heart rate)
时间窗: 5 months
Serum PF-04236921 concentrations will be determined by a validated assay and noncompartmental PK parameters
时间窗: 5 months
次要结局
- Incidence and severity of clinical laboratory abnormalities including absolute neturophil count, hepatic transaminases and bilirubin levels, and lipid profiles(5 months)
- Incidence and level of ADA development(5 months)