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临床试验/JPRN-UMIN000018828
JPRN-UMIN000018828尚未招募1 期

A randomized single-blind phase 1 clinical trial of OSKLIPO-0524, a liposomal cyclosporine, to assess pharmacokinetics and safety in Japanese healthy volunteers - A randomized single-blind phase 1 clinical trial of OSKLIPO-0524, a liposomal cyclosporine, to assess pharmacokinetics and safety in Japanese healthy volunteers

Osaka University Hospital0 个研究点目标入组 20 人开始时间: 2015年9月1日最近更新:
适应症

试验速览

阶段
1 期
状态
尚未招募
入组人数
20

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
20years-old 至 45years-old(—)
性别
Male

入选标准

  • 未提供

排除标准

  • 1) A subject who has cardiovascular,kidney, liver, blood or autoimmune system diseases 2) BMI (kg/m2) <17.5 or >=30.0 3) A subject who has HCV Ab, HIV Ab, HBs Ag positive by screening test 4) A subject who has or is suspected to have the past of clinically significant drug allergy symptoms 5) A subject who has or is suspected to have the past of significant allergic diseases including bronchial asthma, urticaria or atopy, but not seasonal allergy 6) A subject with diseases and symptoms requiring systemic drugs 7) A subject who has or suspeted to have a past histroy of drug or alcohol dependency 8) A subject who received vaccine within four months 9) A subject who participated in other clinical trials within 4 months and received a clinical trial drug (including a placebo) 10) A subject taking prescribed drugs and/or Over-The-Counter drugs 11) Ineligible judged by the investigators

研究者

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