NL-OMON32763已完成不适用
A Phase I, Single-Centre, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of CH-4051 in healthy male subjects - Single and Multiple Ascending Dose Study to Evaluate CH-4051.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •written informed consent • males, 18-55 years of age • physically and mantally in good state of health • body mass index of 18-30 kg/m2 • no abnormalities found at screening
排除标准
- •smoking or stopped smoking less than three months ago • drugs and/or alcohol abuse • drinking more than 21 glasses of alcohol per week • surgery in 3 months prior to study • hepatitis B, C or HIV positive • no history of infection with chicken pox • planning to be vaccinated with a (live) vaccine (yellow fever, MMR, and rubella) during the study • use of prescription medication within 4 weeks prior to the first dosing day • previously or currently receiving MTX • use of over-the-counter medication within 2 weeks prior to the first dosing day • vegetarians, vegans and/or having medical dietary restrictions • relevant food or drug hypersensitivity or allergy • having participated in an investigational drug study within 3 months prior to the dosing day • having donated blood within 12 weeks prior to the (first) dosing day • having a significant infection at screening • having an active viral, bacterial or fungal infection on day -1 • raised body temperature (>38 degrees celsius) on day -1 • taking co-trimoxazole or thrimethoprim • MCV > 95 fL • acute significant gastrointestinal symptoms on day -1 or prior to dosing on day 1.
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