NCT01885624已完成1 期
Open Label Phase 1 Pharmacokinetics and Tolerability Study of Single TAB08 Administration in Healthy Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Theramab LLC
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Incidence of dose-limiting toxicity in every dose cohort
研究概览
简要总结
The purpose of this study is to assess safety and tolerability of ascending dosed of TAB08 after single i.v. infusion to the adult healthy volunteers. Additionally were assessed infusion speed tolerability, pharmacokinetics and pharmacodynamics of TAB08 after single i.v. infusion and to explore TAB mechanism-of-action biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Adult man aged from 18 to 40 years, who agreed to use adequate contraception.
- •Body mass is at least 60 kg and BMI is within 20-27
- •Volunteer is in good physical and mental health, as per his medical history and assessment results
- •Volunteer's laboratory values are normal (or not clinically significant as per Investigator discretion) at screening, including baseline cytokines levels as per RESTORE test results
- •Volunteer has signed the informed concent.
排除标准
- •Any chronic or relapsing illness in the medical history
- •Any abnormal assessment or laboratory result at screening, which is clinically significant as per Investigator discretion
- •Active tuberculosis at the time of screening
- •Any acute illness at the time of study enrollment
- •Any blood donation within 4 weeks before Study Day 1
- •Positive result for HBsAG, Hepatitis C, HIV
- •Continuous use af any medications
- •Use of any medications within 72 hours before study drug infusion
- •Use of an investigational treatment within 4 weeks before screening, or within a period of 5 half-lives of the investigational treatment, whichever is longer
- •High inflammatory cytokines levels as per RESTORE test results after ex vivo PBMC testing
结局指标
主要结局
Incidence of dose-limiting toxicity in every dose cohort
时间窗: From study drug infusion (Day 1) untill the end of study (Day 71/141)
次要结局
未报告次要终点
研究者
研究点 (2)
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