临床试验/NCT00820404

NCT00820404已完成1 期

Ascending Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of BLI-489 Administered Intravenously to Healthy Subjects

Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 54 人开始时间: 2009年1月最近更新: 2009年7月17日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 54
主要终点: Safety as measured by the number of adverse events and serious adverse events. Tolerability will be assessed based upon the occurrence of dose limiting toxicities.

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to evaluate the safety, and tolerability of single doses of BLI-489 administered intravenously in healthy subjects, and also how the drug is absorbed and eliminated.

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: Double

入排标准

年龄范围: 20 Years 至 50 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Men or women of nonchildbearing potential, 18 to 50 years of age inclusive at screening.
•Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight greater than or equal to 50 kg.
•Healthy as determined by the investigator on the basis of the screening evaluations.
•Nonsmoker of smoker of fewer than 10 cigarettes per day as determined by history.

排除标准

•Presence of history of any disorder that may prevent the successful completion of the study.
•History of drug abuse within 1 year.

研究组 & 干预措施

1

Experimental

BLI-489

干预措施: BLI-489 (Drug)

2

Placebo Comparator

Placebo

干预措施: Placebo (Drug)

结局指标

主要结局

Safety as measured by the number of adverse events and serious adverse events. Tolerability will be assessed based upon the occurrence of dose limiting toxicities.

时间窗: 15 days

次要结局

Pharmacokinetics as evaluated by drug concentrations in the blood and urine.(4 days)

研究者

发起方

Wyeth is now a wholly owned subsidiary of Pfizer

申办方类型

Industry

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