A Randomized, Open-Label, Parallel-Arm Study to Assess the Absolute Bioavailability of a Single, Fixed Subcutaneous Dose of Aducanumab (BIIB037) in Healthy Subjects Compared to a Single, Weight-Based Intravenous Dose
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- PK parameter of IV dose of aducanumab: Area under the concentration-time curve from time zero to infinity (AUCinf)
研究概览
简要总结
The primary objectives of this study are to evaluate the absolute bioavailability of a single, fixed sub-cutaneous (SC) dose of aducanumab compared with a single, weight-based intra-venous (IV) dose in healthy participants and to characterize the pharmacokinetics (PK) profile of aducanumab. The secondary objectives are to evaluate the safety and tolerability of aducanumab administered via SC and IV routes in healthy participants and to characterize additional PK parameters of a single, fixed SC dose of aducanumab and a weight-based IV dose in healthy participants.
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
- •A minimum weight of 45 kg, inclusive, at Day -
- •All women of childbearing potential and all men must practice highly effective contraception during the study and be willing and able to continue contraception for 24 weeks after study treatment dosing (Day 1).
- •Must be in good health (as determined by the Investigator) based on the medical history and screening evaluations.
排除标准
- •Mini mental state examination (MMSE) score of <27 at Screening.
- •History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, gastrointestinal, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
- •History of severe allergic or anaphylactic reactions that in the opinion of the Investigator is likely to be exacerbated by any component of the study treatment.
- •History of malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell and squamous cell carcinomas of the skin that have been completely excised prior to study entry).
- •History of, or positive test result at Screening for, human immunodeficiency virus (HIV).
- •Positive test result at Screening for hepatitis C virus antibody (HCVAb).
- •Positive test result at Screening for hepatitis B virus (defined as positive for both, hepatitis B surface antigen [HBsAg] AND hepatitis B core antibody [HBcAb]).
- •Chronic, recurrent, or serious infection (e.g., pneumonia, septicemia) as determined by the Investigator, within 90 days prior to Day -
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
aducanumab IV
Infusion of aducanumab over approximately 1 hour
干预措施: aducanumab (Drug)
aducanumab SC
Subcutaneously via injection
干预措施: aducanumab (Drug)
结局指标
主要结局
PK parameter of IV dose of aducanumab: Area under the concentration-time curve from time zero to infinity (AUCinf)
时间窗: 13 weeks
PK parameter of SC dose of aducanumab: Area under the concentration-time curve from time zero to infinity (AUCinf)
时间窗: 13 weeks
PK parameter of aducanumab: Maximum observed concentration (Cmax)
时间窗: 13 weeks
PK parameter of SC dose of aducanumab: Absolute Bioavailability
时间窗: 13 weeks
PK parameter of SC route of aducanumab: Time to reach maximum observed concentration (Tmax)
时间窗: 13 weeks
次要结局
- PK parameter of aducanumab: Volume of distribution (Vd)(13 weeks)
- PK parameter of aducanumab: Apparent total body clearance (CL/F)(13 weeks)
- Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)(13 weeks)
- Number of participants with clinically significant vital sign abnormalities(13 weeks)
- Number of participants with clinically significant laboratory assessment abnormalities(13 weeks)
- Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities(13 weeks)
- PK parameter of aducanumab: Area under the concentration-time curve from time zero to the time of the last measurable sample (AUClast)(13 weeks)
- PK parameter of aducanumab: Terminal elimination half-life (t1/2)(13 weeks)