此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

A Phase 1 Study of Single-dose Subcutaneous E6011 in Japanese Healthy Adult Male Subjects

2014年10月20日 更新者：Eisai Co., Ltd.
This study (Protocol No. E6011-J081-002) is a single-center, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study to evaluate mainly the safety and tolerability of a single subcutaneous administration of E6011. A total of 32 subjects will be randomized into four cohorts (50, 100, 200 and 400 mg groups). Of eight subjects per cohort, six subjects will receive the single subcutaneous E6011 administration and two subjects will receive the single subcutaneous placebo administration.

研究概览

地位

完全的

条件

干预/治疗

详细说明

This study consists of Screening Period, Observation Period, In-patient Period, and Follow-up Period. Screening assessments will be performed within 28 to 2 days before starting the study treatment, and Observation Period assessments will be performed on a day before starting the study treatment to confirm the eligibility of study subjects. The eligible subjects will be randomized into either E6011 arm or placebo arm using the drug allocation list prepared by the random code statistician. Each subjects dosing interval will be at least a 30-minutes.

研究类型

介入性

注册 (实际的)

32

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 日本
    • Kanagawa
      • Sagamihara、Kanagawa、日本

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 至 44年 (成人)

接受健康志愿者

是的

有资格学习的性别

男性

描述

Inclusion criteria

  1. Non-smoking Japanese male subjects aged greater than or equal to 20 to less than 45 years
  2. BMI at screening is greater than or equal to 18.5 kg/m2 to less than 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

Exclusion criteria

  1. Has been treated with biologic product(s) (except for immunoglobulin)
  2. Has received immunoglobulin or blood preparation within 6 months before the study treatment
  3. Has received inoculation within 4 weeks before the study treatment
  4. Has a history of autoimmune disease or immunodeficiency
  5. Has a history of clinically significant angioedema, hematemesis, anal hemorrhage, or hemoptysis
  6. Has a history of acute myocardial infarction, cerebral infarction, cerebral hemorrhage, or arteriosclerosis obliterans
  7. With gross hematuria, occult bleeding in urine of greater than or equal to 1+ and urine protein of greater than or equal to 1+, or either of greater than or equal to 2+ is found at screening
  8. Has a clinically significant vasculitis (e.g., mononeuritis multiplex)
  9. Known to be positive for human immunodeficiency virus antigen/antibody (HIV antigen/antibody), hepatitis B virus surface antigen (HBs antigen), hepatitis B virus surface antibody (HBs antibody), hepatitis B core virus antibody (HBc antibody), hepatitis B virus (HBV) DNA, hepatitis C virus antibody (HCV antibody), human T cell lymphotropic virus type 1 antibody (HTVL-1 antibody), or syphilis serology test positive at screening.
  10. Known to be positive for tuberculosis test (T-spot.TB Test or QuantiFERON TB Gold Test) at screening.
  11. Treated with ethical drug (except for disinfectants, eye drops) within 4 weeks before the study treatment.
  12. Treated with non-prescription drug (except for disinfectants, eye drops) within 2 weeks before the study treatment.
  13. Has participated in another clinical trial and received an investigational drug or device within 16 weeks before the study treatment.
  14. Received blood transfusion within 1 year, 400 mL or more whole blood donation within 12 weeks, or 200 mL or more whole blood donation within 4 weeks, or blood constituent donation within 2 weeks before the study treatment.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：1
Subcutaneous administration of E6011 50 mg
药品：E6011
Subcutaneous administration of E6011 (at doses of 50, 100, 200 and 400 mg)
实验性的：2
Subcutaneous administration of E6011 100 mg
药品：E6011
Subcutaneous administration of E6011 (at doses of 50, 100, 200 and 400 mg)
实验性的：3
Subcutaneous administration of E6011 200 mg
药品：E6011
Subcutaneous administration of E6011 (at doses of 50, 100, 200 and 400 mg)
实验性的：4
Subcutaneous administration of E6011 400 mg
药品：E6011
Subcutaneous administration of E6011 (at doses of 50, 100, 200 and 400 mg)
安慰剂比较：5
Subcutaneous administration of placebo
药品：安慰剂
安慰剂皮下给药

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Pharmacokinetics of E6011: Maximum Concentration (Cmax)
大体时间：Up to 10 Weeks
Up to 10 Weeks
Pharmacokinetics of E6011: Time to attain Cmax (tmax)
大体时间：Up to 10 Weeks
Up to 10 Weeks
Pharmacokinetics of E6011: Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration AUC(0-t)
大体时间：Up to 10 Weeks
Up to 10 Weeks
Pharmacokinetics of E6011: Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time AUC(0-inf)
大体时间：Up to 10 Weeks
Up to 10 Weeks
Pharmacokinetics of E6011: Elimination half-life (t1/2)
大体时间：Up to 10 Weeks
Up to 10 Weeks
Pharmacokinetics of E6011: CL/F
大体时间：Up to 10 Weeks
Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose/AUC(0-?).
Up to 10 Weeks
Pharmacokinetics of E6011: Apparent Volume of Distribution of Azacitidine (Vz/F)
大体时间：Up to 10 Weeks
Up to 10 Weeks
Safety and Tolerability of E6011
大体时间：Up to 10 Weeks
The safety will be assessed based on all adverse events (AEs), clinical laboratory test, vital signs, body weight, physical finding, administration site finding, electrocardiography and chest xray.
Up to 10 Weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Eisai Co., Ltd.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年9月1日

初级完成 (实际的)

2013年12月1日

研究完成 (实际的)

2014年4月1日

研究注册日期

首次提交

2014年5月21日

首先提交符合 QC 标准的

2014年5月22日

首次发布 (估计)

2014年5月23日

研究记录更新

最后更新发布 (估计)

2014年10月22日

上次提交的符合 QC 标准的更新

2014年10月20日

最后验证

2014年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • E6011-J081-002

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅