A phase 1, single-dose study of E6011 in Japanese healthy adult subjects

Eisai Co., Ltd.0 个研究点目标入组 64 人开始时间: 2012年11月29日最近更新: 2023年10月17日

试验速览

暂无简介。

•1. Non-smoking Japanese males aged between 20 and 44 years old,
•2. BMI at screening is between 18.5 kg/m2 and <25.0 kg/m2,
•3. Males who have not had a successful vasectomy and their female partners must agree to practice highly effective contraception throughout the study period.

•1. Has been treated with biologic products (except for immunoglobulin preparation),
•2. Have received immunoglobulin or blood preparation within 6 months before the study drug administration,
•3. Has a clinically significant angioedema, hematemesis, anal hemorrhage, or hemoptysis,
•4. Has a history of acute myocardial infarction, cerebral infarction, cerebral hemorrhage, or arteriosclerosis abliterate,
•5. With gross hematuria, occult bleeding in urine (greater than or equal to 1+) and urine protein (greater than or equal to 1+), or either of greater than or equal to 2+ at screnning,
•6.Has a clinically significant vasculitis (e.g., multiple mononeuropathy),
•7. Known to be positive for human immunodeficiency virus (HIV antigen and antibody), hepatitis B virus surface antigen (HBs antigen), hepatitis B virus surface antibody (NBs antibody), hepatitis B virus (HBV) DNA, hepatitis C virus (HCV) antibody, or syphilis serology test,
•8. Known to be positive for QuantiFERON-TB Gold Test

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