NL-OMON37404已完成不适用
A Phase I, double blind, placebo-controlled, randomized 4-way alternating cross-over study to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic effects of single ascending doses of ASP3652 in healthy young Caucasian male and female subjects - Single Ascending dose study of ASP3652 in healthy volunteers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Healthy young male or female subject aged 18 to 55 years inclusive.
- •- Subject is white and of Caucasian origin.
- •- Willing to participate and has signed the written subject informed consent form.
排除标准
- •1. Known or suspected hypersensitivity to ASP3652, or any components of the formulation used.
- •2. Pregnancy within 6 months before screening assessment or breast feeding within 3 months before screening (for female subjects only).
- •3. Any of the following liver function tests (ALT, AST, γ-GT , TBL and ALP) above the upper limit of normal. In such case the assessment may be repeated once.
研究者
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