NCT01117233已完成1 期
A Randomised, Placebo Controlled, Double-Blind, Third Party Open, Parallel Group Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04427429 Administered Intravenously To Healthy Adult Volunteers
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
- 40
- 试验地点
- 1
- 主要终点
- Adverse events, Vitals, ECG, laboratory safety tests, IV infusion site reaction
研究概览
简要总结
The purpose is to study the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-04427429 administered intravenously to healthy adult volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects between the ages of 18 and 50 years inclusive (unless local regulations dictate a minimum age of 21 years). 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 and clinical laboratory tests.
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight of between 50 kg and 100 kg inclusive.
- •Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, genitourinary, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, symptomatic, seasonal allergies at time of dosing).
- •Any condition possibly affecting drug absorption.
- •12-lead ECG demonstrating QTcF >450 msec at Screening. If QTcF exceeds 450 msec, the ECG should be repeated two more times and the average of the three QTcF values should be used to determine the subject's eligibility.
研究组 & 干预措施
Single IV Dose 1
Experimental
干预措施: PF-04427429 (Drug)
Single IV Dose 2
Experimental
干预措施: PF-04427429 (Drug)
Single IV Dose 3
Experimental
干预措施: PF-04427429 (Drug)
Single IV Dose 4
Experimental
干预措施: PF-04427429 (Drug)
Single IV Dose 5
Experimental
干预措施: PF-04427429 (Drug)
结局指标
主要结局
Adverse events, Vitals, ECG, laboratory safety tests, IV infusion site reaction
时间窗: up to 84 days
Plasma pharmacokinetics of PF-04427429
时间窗: up to 84 days
次要结局
- Free and total CGRP plasma concentrations(up to 84 days)
- anti-drug antibody(up to 84 days)
研究者
研究点 (1)
Loading locations...
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