NCT02537002已完成1 期
A Phase 1, Randomized, Double-blind, Sponsor-open, Placebo-controlled, Single Ascending Dose Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of An Intravenous Bolus Infusion Pf-05230907 In Healthy Japanese Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events and Serious Adverse Events Per Participant of PF-05230907
研究概览
简要总结
The purpose of this study is the following:
- To determine the safety and tolerability of single ascending intravenous (IV) doses of PF-05230907 in healthy Japanese subjects.
- To characterize the PK profile of single ascending IV doses of PF-05230907 in healthy Japanese subjects.
- To characterize the PD profiles of single ascending IV doses of PF-05230907 in healthy Japanese subjects.
- To evaluate the immunogenicity of PF-05230907 in healthy Japanese subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male of females
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs) and <120 kg (265 lbs).
- •Japanese subjects who have four biologic Japanese grandparents born in Japan.
排除标准
- •Pregnant or nursing females.
- •Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception.
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
研究组 & 干预措施
Cohort 1- PF-05230907 or Placebo
Experimental
干预措施: PF-05230907 (Drug)
Cohort 1- PF-05230907 or Placebo
Experimental
干预措施: Placebo (Drug)
Cohort 2- PF-05230907 or Placebo
Experimental
干预措施: PF-05230907 (Drug)
Cohort 2- PF-05230907 or Placebo
Experimental
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Adverse Events and Serious Adverse Events Per Participant of PF-05230907
时间窗: up to 2 months
次要结局
- Single dose Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]of PF-05230907(Minute 0, 2, 5, 15, 40, 60 minute post-dose)
- Incidence of development of anti-drug antibody (ADA)(up to 2 months)
- Incidence of development of neutralizing antibody (NAb)(up to 2 months)
- Single dose Time to Reach maximum Observed Plasma Concentration (Tmax) of PF-05230907(Minute 0, 2, 5, 15, 40, 60 minute post-dose)
- Single dose Plasma Decay Half-Life (t1/2) of PF-05230907(Minute 0, 2, 5, 15, 40, 60 minute post-dose)
- Single dose clearance (CL) of PF-05230907(Minute 0, 2, 5, 15, 40, 60 minute post-dose)
- Single dose Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (last)]of PF-05230907(Minute 0, 2, 5, 15, 40, 60 minute post-dose)
- Change of aPTT from pre-dose to post-dose(Hour 0, 24 hour post-dose)
- Change of prothrombin fragments 1+2 (PF1+2)(Hour 0, 24 hour post-dose)
- Change of plasma D-dimer(Hour 0, 48 hour post-dose)
- Single dose steady state Volume of Distribution (Vss) of PF-05230907(Minute 0, 2, 5, 15, 40, 60 minute post-dose)
- Single dose Maximum Observed plasma concentration (Cmax) of PF-05230907(Minute 0, 2, 5, 15, 40, 60 minute post-dose)
- Change of factor X activity(up to 2 months)
研究者
研究点 (1)
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