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
- 3
- 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.
研究组 & 干预措施
Placebo
Normal saline
干预措施: Normal saline (Other)
PF-04427429
干预措施: PF-04427429 (Biological)
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)