NCT00677027Unknown1 期
Dose Escalation Safety Study of MM-10-001
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Blood safety parameters
研究概览
简要总结
The purpose of this study is to evaluate the safety of increasing doses of MM-10-001 and to determine the dose of MM-10-001 that enhances the immune system in normal healthy subjects.
详细描述
The drug substance to be studied is a powder produced from shiitake mushroom, containing beta-glucans. The purpose of this study is to evaluate the safety of increasing doses of MM-10-001 and to determine the dose of MM-10-001 that enhances the immune system in normal healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects of both genders, age > 45 years old will be eligible for study.
排除标准
- •Subjects who:
- •Fail to give written informed consent
- •Have BMI over or equal to 30 kg/m2
- •Use corticosteroids (including inhaled steroids) or NSAIDs anti-inflammatory drugs
- •Have uncontrolled hypertension (sitting diastolic blood pressure>95 mmHg)
- •Have on-going allergy or history of anaphylactic reaction
- •Have on-going allergen specific immunotherapy
- •Are immuno-compromised (HIV infected, cancer and other disease affecting the basal immune response)
- •Have chronic inflammatory disease
- •Have diabetes (type 1 or type 2)
- •Have chronic severe renal disease (creatinine outside normal range)
- •Have chronic severe liver disease (ASAT and/or ALAT more than two times the upper limit of the normal range)
- •Have known cardiac failure
- •Have recently (less than 6 months) experienced myocardial infarction
- •Have gastrointestinal diseases (chronic gastritis, IBD, etc.)
- •Have acute or chronic pancreatitis or impaired pancreatic function, or history of pancreatitis
- •Have been vaccinated within the last three months
- •Eat diet supplement NG24 beta-glucan
- •Eat shiitake cheese
- •Have systemic fungal infection
- •Have any clinical condition that renders them unfit to participate including known/suspected drug or alcohol abuse
- •Do not fully understand the content of the informed consent
- •Pregnant and lactating women or women of childbearing potential not using adequate contraception.
结局指标
主要结局
Blood safety parameters
时间窗: every second week
次要结局
- Cell mediated immune response and cytokine production(every second week)
研究者
研究点 (2)
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