ACTRN12612000713897尚未招募1 期
Phase 1 Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of F-652 with a Single Dose in Healthy Male Volunteers.
Generon Corporation Ltd0 个研究点目标入组 40 人开始时间: 2012年7月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- Male
入选标准
- •1.No clinically signifcant findings in medical history and physical examination, especially normal hepatic and renal function.
- •2. BMI >19 and < 30mg/m2
- •3. No clinically significant laboratory values and urinalysis
- •4. Normal Quantiferon test, ECG, blood pressure and heart rate
- •5. Aged between 18 and 45 years
排除标准
- •1. Family history of premature Coronary Heart Disease (CHD)
- •2. Any condition requiring regular use of medication
- •3. Exposure to prescription medication or to drugs known to interfere with metabolism of drugs within 14 days prior to screening.
- •4. Current or history of malignancy disease
- •5. Haemorrhoids or anal disease with regular or recent presence of blood in faeces.
- •6. Presence or sequelae of hepatics and renal disease, or other medical conditions known to intefere with the absorption, distribution, metabolism and excretion of drugs
研究者
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