A Randomized, Blinded, Placebo-Controlled, Single- and Multiple-Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB033 in Healthy Japanese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
The primary objective of this study is to assess the safety and tolerability of a single dose and multiple doses of BIIB033 administered to healthy adult Japanese participants. The secondary objectives of this study are to evaluate the pharmacokinetics (PK) profile of BIIB033 administered as single and multiple doses in healthy adult Japanese participants and to assess the single-dose and multiple-dose immunogenicity of BIIB033.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Japanese subjects must have been born in Japan, and their biological parents and grandparents must all have been of Japanese origin.
- •Subjects who have lived out of Japan for more than 5 years must not have significantly modified their diets since leaving Japan.
- •Must be a nonsmoker or light smoker (<10 cigarettes per day) and be willing to abstain from using tobacco and tobacco-containing products during the Inpatient Period and for at least 48 hours prior to Day -1, Day 14 (for Cohort 3), and all outpatient visits.
- •Must have a body mass index of 18 to 32 kg/m2, inclusive.
排除标准
- •History of any clinically significant cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease, as determined by the Investigator.
- •Serious infection (e.g., pneumonia, septicemia) as determined by the Investigator within the 3 months prior to Day -
- •Fever or bacterial or viral infection (including upper respiratory tract infection) within 2 weeks prior to Day -
- •History of severe allergic or anaphylactic reactions.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
结局指标
主要结局
Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Up to day 113
Number of participants with clinically significant vital sign abnormalities
时间窗: Up to day 113
Number of participants with clinically significant electrocardiograms (ECGs) abnormalities
时间窗: Up to day 113
Number of participants with clinically significant physical examination abnormalities
时间窗: Up to day 113
Number of participants with clinically significant laboratory parameters
时间窗: Up to day 113
Number of participants with clinically significant neurological examination abnormalities
时间窗: Up to day 113
次要结局
- PK parameter of BIIB033: Area under the concentration-time curve from time zero to the time of the last measurable sample (AUClast)(Up to day 113)
- PK parameter of BIIB033: AUC over a given dosing interval(Up to day 113)
- PK parameter of BIIB033: Clearance (CL)(Up to day 113)
- PK parameter of BIIB033: accumulation ratio (RAC)(Up to day 113)
- Number of participants with positive serum BIIB033 antibodies(Up to day 113)
- PK parameter of BIIB033: Area under the concentration-time curve from time zero to infinity (AUCinf)(Up to day 113)
- PK parameter of BIIB033: Maximum observed concentration (Cmax)(Up to day 113)
- PK parameter of BIIB033: Time to reach maximum observed concentration (Tmax)(Up to day 113)
- PK parameter of BIIB033: Terminal elimination half-life (t1/2)(Up to day 113)
- PK parameter of BIIB033: Volume of distribution at steady state (Vss)(Up to day 113)