JPRN-jRCT2080223364未知Unknown
A randomized, double-blind, placebo-controlled, single intravenous ascending dose study of E3112 in Japanese healthy adult male subjects
适应症
试验速览
- 阶段
- Unknown
- 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
入排标准
- 年龄范围
- >= 20age old 至 <= 44age old（—）
- 性别
- Male
入选标准
- •Main Inclusion Criteria
- •1. Non-smoking, Japanese male subject, age >=20 and <45 years old at the time of obtaining informed consent
- •2. BMI >=18.5 and <25.0 kg/m2 at Screening
- •3. Provide written informed consent of their free will
- •4. Subject who was given full explanation of all the requirements of the protocol, and are willing and able to comply with them
排除标准
- •Main Exclusion Criteria
- •1. Subject and his partner do not agree to use a highly effective method of contraception throughout the entire study period, if he has reproductive capacity
- •2. Subject who had or has any malignant tumor, lymphoma, leukaemia, or lymphoproliferative disorders. Clinically significant illness that required medical treatment within 8 weeks or a clinically significant infection within 4 weeks prior to dosing
- •3. Evidence of disease that may influence the outcome of the study within 4 weeks prior to dosing
- •4. Any history of surgical treatment that may affect PK profiles of study drug at Screening
- •5. Any suspected clinically abnormal symptom or organ impairment that requires medical treatment at Screening or Baseline
- •6. Receipt of vaccination within 4 weeks prior to dosing
- •7. History of drug or alcohol dependency or abuse
- •8. Intake of caffeinated beverages or food within 72 hours prior to dosing
- •9. Use of prescription drugs within 4 weeks prior to dosing
- •10. Intake of over-the-counter [OTC] medications within 2 weeks prior to dosing
- •11. Subject who is currently being enrolled in another clinical study or used any investigational drug or device in another clinical study within 16 weeks prior to dosing
- •12. Subject who underwent blood transfusion within 12 weeks, or who donated 400 mL or more of whole blood within 12 weeks or 200 mL or more of whole blood within 4 weeks, or who made a component donation within 2 weeks prior to dosing
研究者
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