A Phase 1, Randomized, Double-blind, Sponsor-open, Placebo-controlled, Single Ascending Dose Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-05230907 In Healthy Subjects
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
- 1
- 主要终点
- Incidence of dose limiting treatment related adverse events
研究概览
简要总结
The purpose of this study is to determine what the study drug does to the body, what the body does to the study drug, and if the study drug is safe and well tolerated when given to adult healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects.
- •Healthy non-child bearing female subjects.
- •18 to 35 years of age.
排除标准
- •Heart disease.
- •Clotting disorders.
- •Use of nicotine products.
- •Diabetes.
研究组 & 干预措施
PF-05230907 and Placebo Cohort 1
干预措施: PF-05230907 (Biological)
PF-05230907 and Placebo Cohort 1
干预措施: Placebo for PF-05230907 (Drug)
PF-05230907 and Placebo Cohort 2
干预措施: PF-05230907 (Biological)
PF-05230907 and Placebo Cohort 2
干预措施: Placebo for PF-05230907 (Drug)
PF-05230907 and Placebo Cohort 3
干预措施: PF-05230907 (Biological)
PF-05230907 and Placebo Cohort 3
干预措施: Placebo for PF-05230907 (Drug)
PF-05230907 and Placebo Cohort 4
干预措施: PF-05230907 (Biological)
PF-05230907 and Placebo Cohort 4
干预措施: Placebo for PF-05230907 (Drug)
PF-05230907 and Placebo Cohort 5
干预措施: PF-05230907 (Biological)
PF-05230907 and Placebo Cohort 5
干预措施: Placebo for PF-05230907 (Drug)
PF-05230907 and Placebo Cohort 6
干预措施: PF-05230907 (Biological)
PF-05230907 and Placebo Cohort 6
干预措施: Placebo for PF-05230907 (Drug)
结局指标
主要结局
Incidence of dose limiting treatment related adverse events
时间窗: Through Day 43
Incidence, severity and causal relationship of treatment emergent adverse events, treatment emergent serious adverse events, and withdrawals due to treatment emergent adverse events
时间窗: Through Day 43
Incidence and magnitude of treatment emergent abnormal laboratory findings
时间窗: Through Day 43
Change from baseline in vital sign measurements, ECG parameters, and physical examinations
时间窗: Through Day 43
次要结局
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)(Through 4 hour post dose Day 1)
- Maximum Observed Plasma Concentration (Cmax)(Through 4 hour post dose Day 1)
- Pharmacodynamic activity as measured by thrombin-antithrombin (TAT) complexes(Through post dose Day 2)
- Pharmacodynamic activity as measured by prothrombin fragments 1+2 (PF1+2)(Through post dose Day 2)
- Pharmacodynamic activity as measured by D-dimer(Through post dose Day 7)
- Pharmacodynamic activity as measured by prothrombin time/internationalize normalized ration (PT/INR)(Through post dose Day3)
- Pharmacodynamic activity as measured by activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT)(Through post dose Day3)
- Pharmacodynamic activity as measured by protein C activity(Through post dose Day 2)
- Pharmacodynamic activity as measured by Factor V activity(Through post dose Day 3)
- Incidence of antibody immune response(Through post dose Day 43)
- Factor X activity(Through post dose Day 43)