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临床试验/EUCTR2012-001709-26-CZ
EUCTR2012-001709-26-CZ进行中(未招募)1 期

Randomized, double-blind, placebo-controlled clinical trial of Immodin immunological efficacy in healthy adult volunteers. - not available

Sevapharma,a.s.0 个研究点开始时间: 2012年5月11日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Subjects must have signed an approved informed consent after full information
  • Subjects meet the conditions of healthy individuals or eventual blood donors.
  • Subjects in good health with no acute illness last 4 weeks.
  • Men and women aged 18 to 30 years.
  • Subjects meet the conditions of cellular immunity within the normal range.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 60
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Subject with acute infectious diseases.
  • Subject with immunodeficiency, including allergic diseases (anamnestically).
  • Pregnant woman and breastfeeding (anamnestically).
  • Woman at fertile age without adequate contraception (barrier and hormonal) or without practicing sexual abstinence.
  • Subject allergic to any of the substances of the investigational medicinal product administered in clinical trial.
  • Inability of cooperation or irresponsibility.
  • Current participation in another clinical trial or in drug evaluation, within 4 weeks prior to study entry.
  • Known or suspected history of alcoholism or drug abuse.
  • Unwillingness to sign informed consent.
  • Dependents (eg conscripts, persons dependent on the researcher - such as subordinates, family members).

研究者

发起方
Sevapharma,a.s.

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