ISRCTN79241600已完成不适用
A double-blind, placebo-controlled, single and multiple ascending dose phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of CCX507-B in healthy male and female subjects
ChemoCentryx, Inc. (USA)0 个研究点目标入组 30 人开始时间: 2014年5月23日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
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. Male or female subjects, aged 18-65 inclusive
- •2. Willing and able to give written Informed Consent and to comply with the requirements of the study protocol
- •3. Negative result of the human immunodeficiency virus (HIV) screen, the hepatitis B screen, and the hepatitis C screen
- •4. Female subjects of childbearing potential, and male subjects with partners of childbearing potential, may participate if adequate contraception is used
排除标准
- •1. Women who are pregnant or breastfeeding
- •2. History of use of tobacco and/or nicotine-containing products within the 3 months prior to study entry
- •3. History of drug abuse within 1 year prior to study entry
- •4. History of alcohol abuse within 5 years prior to study entry
- •5. History of any form of cancer
- •6. Consumed alcoholic beverages, or any food or drink containing grapefruit or Seville oranges within 48 hours prior to Day -1
- •7. History or presence of any medical condition or disease which, in the opinion of the Investigator, may place the subject at unacceptable risk for study participation
- •8. Donated or lost more than 50 mL of blood or blood products within 56 days prior to screening, or donated plasma within 7 days of randomization
- •8. Subject's hemoglobin less than the lower limit of normal at screening
- •9. Participated in any clinical study of an investigational product within 60 days prior to randomization
- •10. Subject has any evidence of hepatic disease; aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, or bilirubin > 1.5 x the upper limit of normal
- •11. Subject has any evidence of renal impairment; serum creatinine > 1.5 x upper limit of normal
- •12. Subject's urine tested positive at Screening and/or on Study Day -1 for any of the following: opioids, amphetamines, cannabinoids, benzodiazepines, barbiturates, cocaine, cotinine, or alcohol
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