ISRCTN40071144已完成1 期
A phase I, double-blind, randomised, placebo-controlled, dose escalating study to assess the safety, tolerability, and pharmacokinetics of single and multiple doses of NVB302 administered orally to healthy volunteers
ovacta Biosystems Limited (UK)0 个研究点目标入组 72 人开始时间: 2011年8月16日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
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
- 性别
- All
入选标准
- •1. Healthy male and female subjects, between 18 and 64 years of age (inclusive)
- •2. Female subjects must be postmenopausal or surgically sterilised
- •3. Female subject of non-child bearing potential with negative pregnancy test at screening
- •4. Male subjects must be willing to use an effective method of contraception from day 1 until 3 months afterwards
- •5. Subject has a healthy gastro-intestinal (GI) tract with no clinically significant history of GI disease (including any disorder likely to influence drug absorption) or bowel surgery
排除标准
- •1. Any relevant abnormality in medical history or on examination, including history of dementia, or other psychiatric, neurological, immunological, respiratory or cardiovascular disorder
- •2. Presence of Clostridium difficile toxin in faecal sample
- •3. Participation in a clinical study of an unlicensed drug in the previous 16 weeks, or a marketed drug study within the previous 12 weeks
- •4. Known allergies, including allergy to drugs with a similar chemical structure or class to NVB302 (Type B lantibiotics) or its constituents
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