NCT01841476已完成1 期
POL6326 - A Phase I, Open, Single Intravenous Infusion Dose, Pharmacokinetic and Pharmacodynamic Study in Healthy Volunteers Who Are Volunteering as Haematopoietic Stem Cell (HSC) Donors
Polyphor Ltd.1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2012年2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
- 27
- 试验地点
- 1
- 主要终点
- Safety of single ascending doses of POL6326 by intravenous infusion according to standard criteria
研究概览
简要总结
Phase I study to determine and compare the safety/tolerability of single ascending doses of POL6326 by intravenous infusion.
详细描述
Phase I Study
- to determine and compare the safety of single ascending doses of POL6326 by intravenous infusion
- to determine the relationship between 2-hour single intravenous infusion doses of POL6326 and the concentration of HSC and mature WBC in peripheral blood using immunophenotypic assays.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Mobilization and collection of hematopoietic stem cells (HSCs) using G-CSF at least 6 weeks but less than 6 months prior to protocol enrollment.
- •Ages greater than or equal to 18 years and less than or equal to 55 years.
- •Normal liver and renal function, normal CBC, normal ECG, normal blood pressure including adequately medically controlled idiopathic arterial hypertension, no other contraindications to mobilized peripheral blood stem cell donation according to WMDA criteria and relevant SOPs at the study site defining additional exclusion criteria for stem cell donation.
- •Subject must be eligible for normal blood donation according to requirements for IDMs as laid out by national law for blood donors.
- •Ability to comprehend the investigational nature of the study and provide informed consent.
排除标准
- •Active infection or history of recurrent infection- hepatitis B and C (HBsAg, Anti-HBc, Anti-HCV), HIV and HTLV-
- •History of autoimmune disease such as rheumatoid arthritis, systemic lupus erythematous.
- •History of cancer within the past 5 years excluding basal cell or squamous cell carcinoma of the skin.
- •History of any hematologic disorders including thromboembolic disease.
- •History of cardiac disease such as uncontrolled hypertension, peripheral vascular disease, myocardial infarction, cardiac arrhythmias OR related symptoms such as tachycardia, chest pain, shortness of breath which have required medical intervention OR treatment or a Framingham coronary disease risk prediction score of greater than 10% 10 year coronary heart disease (CHD) risk.
研究组 & 干预措施
POL6326
Experimental
2-hour single intravenous infusion doses of POL6326
干预措施: POL6326 (Drug)
结局指标
主要结局
Safety of single ascending doses of POL6326 by intravenous infusion according to standard criteria
时间窗: 2 days
Safety as measured by the incidence, type and severity of adverse events.
次要结局
- Pharmacokinetic outcome(24h)
- Mobilisation of CD34+ cells(2 days)
研究者
研究点 (1)
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