A Phase 1, Randomized, Double Blind, Sponsor-open, Placebo-controlled, First-in-human Trial To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Pf-06730512 After Single And Multiple Ascending Intravenous Infusion Or Subcutaneous Administration To Healthy Adult Subjects And An Open-label Evaluation In Healthy Japanese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Number of subjects with injection site reaction(s)
研究概览
简要总结
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of escalating single and multiple intravenous (IV) infusions and subcutaneous (SC) injections of PF-06730512 in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, 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 female subjects of nonchildbearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure (BP) and pulse rate (PR) measurement, 12-lead electrocardiogram (ECG), or clinical laboratory tests.
- •Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
排除标准
- •History of allergic reactions to diagnostic or therapeutic protein. History of recurrent infections or active infection within 28 days of screening.
- •Exposure to live vaccines within 28 days of screening.
- •History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb), or hepatitis C antibody (HCVAb). As an exception, a positive hepatitis B surface antibody (HBsAb) finding as a result of subject vaccination is permissible.
研究组 & 干预措施
PF-06730512
Study Drug being used in the study
干预措施: PF-06730512 (Biological)
Placebo
Placebo for IV/SC administration
干预措施: Placebo (Drug)
结局指标
主要结局
Number of subjects with injection site reaction(s)
时间窗: Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)
Number of subjects with injection site reaction(s)
Number of subjects with laboratory test findings of potential clinical importance
时间窗: Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)
Number of subjects with laboratory test findings of potential clinical importance
Number of Subjects With Treatment Emergent Treatment-Related Adverse Event(s)
时间窗: Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)
Number of Subjects With Treatment Emergent Treatment-Related Adverse Event(s)
Number of subjects with vital signs findings of potential clinical importance
时间窗: Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)
Number of subjects with vital signs findings of potential clinical importance
Number of subjects with ECG findings of potential clinical importance
时间窗: Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)
Number of subjects with ECG findings of potential clinical importance
次要结局
- Clearance (CL) or Apparent Clearance (CL/F) of PF-06730512, as permitted(Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose))
- Apparent Volume of Distribution of PF-06730512, as permitted(Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose))
- Maximum Observed Plasma Concentration (Cmax) of PF-06730512(Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose))
- Incidence of the development of anti-drug antibody (ADA) and neutralizing antibody (NAb)(Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose))
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] of PF-06730512, as permitted(Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose))
- Minimum observed concentration during the dosing interval (Cmin)(Day 1 to approximately Day 113)
- Time to Reach Maximum Observed Concentration (Tmax) of PF-06730512(Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose))
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06730512(Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose))
- Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06730512(Day 1 to approximately Day 113)
- Terminal half-life, as permitted(Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose))
- Accumulation ratio (Rac), as permitted(Day 1 to approximately Day 113)