A Randomized, Placebo Controlled, Double-Blind, Third Party Open, Ascending Dose Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04427429 Administered Intravenously To Healthy Female Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 31
- 试验地点
- 4
- 主要终点
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of this study is to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-04427429 in healthy women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Generally healthy women, of non-child bearing potential, between the ages of 18 and 65 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG or clinical laboratory tests.
- •Body Mass Index (BMI) of 17.5 to 35.0 kg/m2; and a total body weight between 50 kg (110 lbs) and 120 kg (265 lbs) inclusive.
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, hepatic, psychiatric, or neurologic, disease. Subjects with asymptomatic, seasonal allergies at the time of dosing will not be excluded.
- •Women of childbearing potential.
- •History or diagnosis of ocular disease or conditions that would confound the assessment of ocular safety, such as diabetic retinopathy, uveitis, severe wet or dry AMD.
结局指标
主要结局
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Screening up to Day 168
Incidence and severity of clinical laboratory abnormalities.
时间窗: Screening up to Day 168
Mean change from baseline and placebo in blood pressure (BP).
时间窗: Screening up to Day 168
Mean change from baseline in 12-lead electrocardiogram (ECG) parameters compared to baseline and placebo.
时间窗: Screening up to Day 168
Categorical summary of QTcF compared to baseline between dose groups and placebo.
时间窗: Screening up to Day 168
Anti-Drug Antibodies (ADA) responses.
时间窗: From Day 0 up to Day 168 and until levels return to baseline.
Intravenous (IV) injection site reactions.
时间窗: Day 1 post dose
Mean change from baseline and placebo in pulse rate (PR).
时间窗: Screening up to Day 168
Mean change from baseline and placebo in body temperature.
时间窗: Screening up to Day 168
次要结局
- Area under the concentration-time curve from zero to infinite time postdose (AUCinf).(Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168)
- Time to maximum concentration (Tmax).(Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168)
- Maximum concentration (Cmax).(Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168)
- Area under the concentration-time curve from zero to the last quantifiable concentration (AUClast).(Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168)
- Terminal elimination half-life (t½).(Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168)
- Clearance (CL).(Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168)
- Volume of distribution (Vz).(Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168)