NCT00434746已完成1 期
Ascending Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ILV-094 Administered IV and One Dose of SC Administered to Healthy Subjects
Wyeth is now a wholly owned subsidiary of Pfizer1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2007年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- To provide safety, tolerability, PK and immunogenicity profiles
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of ascending single IV doses of ILV-094 (an investigational drug) and one SC dose of ILV-094 in healthy subjects.
详细描述
This is a randomized, double-blind, placebo-controlled, inpatient/outpatient, sequential-group study of ascending single IV doses of ILV-094 administered to healthy Japanese male subjects.
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 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men aged 20 to 45 years inclusive at screening.
- •Body mass index in the range of 17.6 to 26.4 kg/m2 and body weight>
- •Nonsmoker or smoker of fewer than 10 cigarettes per day. Must be abstain from smoking during inpatient stay.
- •Healthy as determined by the investigator on the basis of screening evaluation.
排除标准
- 未提供
结局指标
主要结局
To provide safety, tolerability, PK and immunogenicity profiles
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Study Evaluating IMA-638 in Healthy JapaneseHealthyNCT00340327Wyeth is now a wholly owned subsidiary of Pfizer
已完成
1 期
Study Evaluating the Pharmacokinetics of HCV-796 in Healthy Japanese MenHealthyNCT00385190Wyeth is now a wholly owned subsidiary of Pfizer24
已完成
1 期
A Study of MK-8189 in Participants With Schizophrenia (MK-8189-014)SchizophreniaNCT05406440Merck Sharp & Dohme LLC53
撤回
1 期
A Study of Oral Foralumab in Participants With Moderate to Severely Active Crohn's DiseaseCrohn's DiseaseNCT05028946Tiziana Life Sciences LTD
已完成
1 期
A Phase 1, 2-Part, Single Ascending Dose Assessment of the Safety, Tolerability, and Pharmacokinetics of Rolapitant Intravenous in Healthy VolunteersChemotherapy-induced Nausea and VomitingNCT02382666Tesaro, Inc.100