临床试验/NCT00854009

NCT00854009已完成1 期

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

Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 40 人开始时间: 2009年2月20日最近更新: 2018年9月27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: 40
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 Japanese male subjects, and 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 (Participant, Investigator)

入排标准

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

入选标准

•Men, aged 20 to 50 years of age inclusive at screening.
•Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight ≥45 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

责任方

Sponsor

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