An Open-Label, Parallel-Group, Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BG00012 in Chinese, Japanese, and Caucasian Adult Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Cmax of BG00012
研究概览
简要总结
This is an open-label, parallel-group study to evaluate the PK, safety, and tolerability of two different dose regimens of BG00012 over a 24-hour period to adult Chinese, Japanese, and Caucasian healthy volunteers.
详细描述
The purpose of this healthy volunteer study is to provide pharmacokinetic and safety data for two different dose regimens of BG00012. The study will evaluate BG00012 administered over a 24-hour period.
The study will be conducted in male and female Chinese, Japanese, and Caucasian healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Must give written informed consent and any authorizations required by local law
- •All subjects must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.
排除标准
- •History of any clinically significant cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator.
- •History of malignancy (subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible)
- •History of severe allergic or anaphylactic reactions
- •Known history of or positive test result for Human Immunodeficiency Virus (HIV)
- •Serious infection (e.g., pneumonia, septicemia) within 2 months prior to Screening.
- •Female subjects who are pregnant or currently breastfeeding
研究组 & 干预措施
Chinese Subjects - Dose 1 BG00012
干预措施: BG00012 Dose 1 (Drug)
Chinese Subjects - Dose 2 BG00012
干预措施: BG00012 Dose 2 (Drug)
Japanese Subjects - Dose 1 BG00012
干预措施: BG00012 Dose 1 (Drug)
Japanese Subjects - Dose 2 BG00012
干预措施: BG00012 Dose 2 (Drug)
Caucasian Subjects - Dose 1 BG00012
干预措施: BG00012 Dose 1 (Drug)
Caucasian Subjects - Dose 2 BG00012
干预措施: BG00012 Dose 2 (Drug)
结局指标
主要结局
Cmax of BG00012
时间窗: First dose to 24 hours
AUC of BG00012
时间窗: First dose to 24 hours
次要结局
- Number of Adverse Events, as a measure of safety and tolerability(Subjects will be followed for the duration of the study, an expected 20 days)
- Number of Serious Adverse Events, as a measure of safety and tolerability(Subjects will be followed for the duration of the study, an expected 20 days)