NCT00682370已完成1 期
Dose Escalation, Randomized, Placebo Controlled Study to Investigate the Effects of Intravenous Heme Arginate on Heme Oxygenase-1 (HO-1) and Heme Metabolism in Association With HO-1 Gene GTn Promoter Polymorphism in Healthy Male Subjects
Daniel Doberer1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2007年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- The maximal HO-1 mRNA expression in PBMCs
研究概览
简要总结
Heme oxygenase 1 (HO-1) serves as a protective gene. It has been shown that one factor modulating HO-1 activity is a genetic variation in the HO-1 gene (functional GT length polymorphism in the promotor region). Heme arginate is a strong inducer of HO-1 as shown in several animal experimental studies. The aim of this clinical trial is to evaluate the HO-1 stimulation of heme arginate in healthy humans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent prior to any study-mandated procedure.
- •Male aged between 18 and 45 years (inclusive) at screening.
- •No clinically significant findings on the physical examination at screening.
- •Body mass index (BMI) between 18 and 28 kg/m2 (inclusive) at screening.
- •12-lead ECG without clinically relevant abnormalities at screening.
- •Hematology, clinical chemistry, and urinalysis test results not deviating from the normal range to a clinically relevant extent at screening.
- •Negative results from urine drug screen at screening.
- •Ability to communicate well with the investigator, in the local language, and to understand and comply with the requirements of the study.
排除标准
- •Known hypersensitivity to the study drug or any excipients of the drug formulation.
- •Treatment with another investigational drug within 3 months prior to screening.
- •History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening.
- •History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drugs.
- •Smoking within the last 3 months prior to screening.
- •Previous treatment with any prescribed or OTC medications (including herbal medicines such as St John's Wort) within 2 weeks prior to screening.
- •Loss of 250 ml or more of blood within 3 months prior to screening.
- •Positive results from the hepatitis serology, except for vaccinated subjects, at screening.
- •Positive results from the HIV serology at screening.
- •Presumed non-compliance.
- •Legal incapacity or limited legal capacity at screening.
研究组 & 干预措施
A1
Experimental
0.3 mg/kg heme arginate
干预措施: heme arginate (Drug)
A2
Experimental
1 mg/kg heme arginate
干预措施: heme arginate (Drug)
A3
Experimental
3 mg/kg heme arginate
干预措施: heme arginate (Drug)
P
Placebo Comparator
Placebo
干预措施: saline solution (Drug)
结局指标
主要结局
The maximal HO-1 mRNA expression in PBMCs
时间窗: 2 months
次要结局
未报告次要终点
研究者
Daniel Doberer
Studienleiter
Medical University of Vienna
研究点 (1)
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