NCT01026350Unknown1 期
Safety and Efficacy of Oral Colostrum Derived Anti Influenza Antibodies in Healthy Volunteers
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- alterations in immune response to flu antigen
研究概览
简要总结
Administration of colostrum enriched with anti-Flu antibodies may alter host's response to the flu virus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers ages 18-60
- •If participating in sexual activity that could lead to pregnancy, the study volunteer must agree that two reliable methods of contraception will be used simultaneously while receiving the protocol-specified medication and for 1 month after stopping the medication
- •Men > 18 years.
- •Ability and willingness of subject to provide informed consent
- •Screening tests' results within 15% of normal values
排除标准
- •Continuous use of the following medications for more than 3 days within 30 days of study entry:
- •Immunosuppressives
- •Immune modulators
- •Systemic glucocorticoids
- •Anti-neoplastic agents
- •Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- •Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to entry.
- •Subjects with a clinically significant infectious, immune mediated or malignant disease
- •Subjects with anemia (Hb <10.5 gm/dl)
- •Subjects with thrombocytopenia (platelets <100K/µl)
- •Subjects with lymphopenia (absolute lymphocyte count <0.7)
- •Subjects who were previously vaccinated against flu.
- •Subject who received any vaccination within the last 6 months
结局指标
主要结局
alterations in immune response to flu antigen
时间窗: during and after administration of colostrum enriched with anti flu antibodies
次要结局
未报告次要终点
研究者
研究点 (2)
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