NL-OMON42731撤回不适用
A study in healthy volunteers to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses of BN201, an investigational compound for the treatment of acute optic neuritis. - BN201 SAD MAD study
Bionure Pharma S.L. Barcelona0 个研究点目标入组 32 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 32
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 male or female
- •- 18-55 years old inclusive
- •- BMI between 18.0 - 32 kg/m2
- •- smokes less than 6 cigarettes per day (or 1 cigar or pipe)
排除标准
- •strenuous activity (e.g. sports) is not allowed from 96 hours (4 days) prior to entry into the clinical research center and during your stay in the clinical research center. you are not allowed to eat or drink (fast) from 4 hours prior to the pre-study screening, from 4 hours prior to entry into the clinical research center and from 4 hours prior to the poststudy screening .you are not allowed to consume any methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, *powerdrinks*) or alcohol, from 48 hours (2 days) prior to entry into the clinical research center and during your stay in the clinical research center. you are not allowed to consume any foods containing poppy seeds from 48 hours (2 days) prior to the prestudy screening and entry into the clinical research center as this could cause a false-positive drug screen result. you are not allowed to use any prescribed medication during 30 days prior to entry into the clinical research center until the poststudy screening .you are not allowed to use any over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (e.g. St. John*s Wort), from 14 days prior to entry into the clinical research center until the poststudy screening. you are not allowed to have had a serious infection (e.g., pneumonia) within 2 months before the pre-study screening. you are not allowed to have had an active bacterial or viral infection and fever (body temperature >38°C) within 48 hours (2 days) prior to the first administration of the study compound.
研究者
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