A Randomized, Open-Label, Parallel-Arm Study to Assess the Absolute Bioavailability of a Single, Fixed Subcutaneous Dose of Aducanumab (BIIB037) Compared to a Single, Weight-Based Intravenous Dose in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Area Under the Concentration-Time Curve from Time 0 to Infinity (AUCinf) of Aducanumab
研究概览
简要总结
The primary objective of this study is to evaluate the absolute bioavailability of a single, fixed subcutaneous (SC) dose of aducanumab compared with a single weight-based intravenous (IV) dose of aducanumab in healthy volunteers.
The secondary objectives of this study are to assess the safety and tolerability of aducanumab administered SC in healthy volunteers and to characterize additional pharmacokinetic (PK) parameters of a single, fixed SC dose of aducanumab and a weight-based IV dose of aducanumab in 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a body mass index (BMI) between 18 and 30 kilograms per meter square (kg/m^2), inclusive.
- •Have a negative test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on Day -
排除标准
- •History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the investigator.
- •History of severe allergic, anaphylactic, or systemic hypersensitivity reactions, or of any allergic reactions that in the opinion of the investigator are likely to be exacerbated by aducanumab, the excipients contained in the formulation, and if appropriate, and diagnostic agents to be administered during the study.
- •Chronic, recurrent, or serious infection (e.g., pneumonia, septicemia), as determined by the investigator, within 90 days prior to screening or between screening and Day -
- •Any immunization or vaccination given within 10 days prior to Day 1 and for 10 days after Day
- •Current enrollment in any other drug, biological, device, or clinical study, or treatment with an investigational drug or approved therapy for investigational use within 30 days prior to Day -1, or 5 half-lives, whichever is longer.
- •Prior exposure to the study treatment or previous participation in this study or previous studies with aducanumab.
- •Mini mental state examination (MMSE) score of <27 at screening.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Aducanumab Intravenous
Participants will receive aducanumab as body weight-based dose, via IV infusion for approximately 1 hour on Day 1.
干预措施: Aducanumab (Drug)
Aducanumab Subcutaneous
Participants will receive aducanumab as fixed dose, via SC injection on Day 1.
干预措施: Aducanumab (Drug)
结局指标
主要结局
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUCinf) of Aducanumab
时间窗: Up to Day 85
Maximum Observed Concentration (Cmax) of Aducanumab
时间窗: Up to Day 85
次要结局
- Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to Day 85)
- Number of Participants with Clinically Significant Abnormalities in Laboratory Assessments(Up to Day 85)
- Area Under the Concentration-Time Curve from Time 0 to Time of the Last Measurable Concentration (AUClast) of Aducanumab(Up to Day 85)
- Volume of Distribution (Vd) or Apparent Volume of Distribution (V/F) of Aducanumab(Up to Day 85)
- Clearance (CL) or Apparent Clearance (CL/F) of Aducanumab(Up to Day 85)
- Time to Reach Maximum Observed Concentration (Tmax) for Aducanumab Administered SC(Up to Day 85)
- Elimination Half-Life (t½) of Aducanumab(Up to Day 85)
- Number of Participants with Clinically Significant Abnormalities in Vital Signs(Up to Day 85)
- Number of Participants with Clinically Significant Abnormalities in 12-Lead Electrocardiograms (ECGs)(Up to Day 85)