NCT01397838Unknown1 期
Phase 1 Study of an Oral Pro-boneTM, Administered to Post Menopausal Osteopenic Women
OsteoBuild Ltd.0 个研究点目标入组 20 人开始时间: 2011年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 主要终点
- Adverse events recorded throughout the study
研究概览
简要总结
Recent studies have shown that inhibition of Aquaporine-9 channels may ameliorate the bone degradation process. Pro-bone is an AQ - 9 channels inhibitor. This study is design to evaluate the safety of Pro-bone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •BMD as measured by DEXA at screening, should range between (-1)to (-2.5) SD from normal values.
- •At least 12 months of spontaneous amenorrhea or at least 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
- •Study participants not taking estrogen alone or estrogen/progestin containing drug products.
- •Study participants not taking any anti-osteoporosis treatment for at list one year.
- •The following washout periods should be before baseline assessments are made for subjects previously on estrogen alone or estrogen/progestin containing products:
- •8 weeks or longer for any prior use of estrogen and/or progestin products.
- •6 months or longer for prior progestin injectable drug therapy.
- •Women between 45 and 65 years (inclusive) of age.
- •BMI 22-30 (inclusive)
- •Non-smoking (by declaration) for a period of at least 6 months.
- •Subjects able to adhere to the visit schedule and protocol requirements and be available to complete the study.
- •Subjects who provide written informed consent.
排除标准
- •Women have documentation of a positive screening mammogram (obtained at screening or within 9 months of study enrolment) or abnormal clinical breast examination prior to enrolment in clinical studies.
- •Known history of significant medical disorder, which in the investigator's judgment contraindicates administration of the study medications.
- •Any clinically significant abnormality, upon physical examination or in clinical laboratory test, at screening visit.
- •Known history of drug or alcohol abuse according to participant declaration at screening visit.
- •Any acute medical situation (e.g. acute infection) within 48 hours of study start, which is considered of significance by the Principal Investigator.
- •Subjects who are non-cooperative or unwilling to sign consent form.
研究组 & 干预措施
Pro-Bone
Experimental
干预措施: Pro-Bone (Drug)
结局指标
主要结局
Adverse events recorded throughout the study
时间窗: 4 weeks
Blood and urinalysis values assessed at pre-dose and according to study design.
时间窗: 4 weeks
次要结局
- Vital signs(4 weeks)
研究者
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