NCT01815827已完成1 期
An Open-label, Parallel Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of Inclacumab in Japanese Healthy Volunteers Compared to Caucasian Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 62
- 主要终点
- Pharmacokinetics: Area under the concentration-time curve (AUC)
研究概览
简要总结
This open-label, parallel group study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of inclacumab in Japanese healthy volunteers compared to Caucasian healthy volunteers. Subjects will receive a single intravenous dose of inclacumab. Follow-up will be for up to 197 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female volunteers, 18 to 55 years of age, inclusive Healthy status as defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination
- •Japanese subjects must have Japanese parents and grandparents who were born in Japan
- •Caucasian subjects must have Caucasian parents and grandparents
- •Body mass index (BMI) 18 - 30 kg/m2 inclusive
排除标准
- •Clinically significant abnormalities in laboratory test results (including positive test for HIV, hepatitis B and/or C), vital signs or ECGs
- •Any confirmed significant allergic reactions against any drug, or multiple allergies (non-active hay fever is acceptable)
- •Smokes more than 5 cigarettes per day during the three months prior to study conduct
- •Participation in an investigational drug or device study within 30 days or 5 half-lives prior to screening
- •Positive test for drugs of abuse
- •Any suspicion of or history of alcohol and/or other substance abuse or addiction
- •Pregnant or lactating women
研究组 & 干预措施
Caucasian Healthy volunteers
Active Comparator
干预措施: inclacumab (Drug)
Japanese Healthy volunteers
Experimental
干预措施: inclacumab (Drug)
结局指标
主要结局
Pharmacokinetics: Area under the concentration-time curve (AUC)
时间窗: up to 197 days
Pharmacokinetics: Maximum plasma concentration (Cmax)
时间窗: up to 197 days
次要结局
- Pharmacodynamics: Plasma (free and total) soluble P-selectin(up to 197 days)
- Pharmacodynamics: Blood platelet leukocytes aggregation (PLA)(up to 197 days)
- Safety: Incidence of adverse events(approximately 10 months)
研究者
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