NCT05216887已完成1 期
A Randomized, Open-Label, Parallel-Arm Study to Assess the Pharmacokinetic Comparability of 2 Fixed Subcutaneous Doses of Aducanumab (BIIB037) With a Single, Weight-Based Intravenous Dose in Healthy Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 123
- 试验地点
- 6
- 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 the study is to evaluate the pharmacokinetic (PK) comparability of 2 fixed subcutaneous (SC) doses of aducanumab with a single, weight-based intravenous (IV) dose of aducanumab in healthy volunteers. The secondary objectives of the study are to assess the safety and tolerability of aducanumab administered SC in healthy volunteers and to characterize additional PK parameters of 2 fixed SC doses of aducanumab and a single, weight-based IV dose of aducanumab.
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
- 是
入选标准
- •Have a body mass index between 18 and 30 kilograms per meter square (kg/m^2), inclusive
- •Japanese participant has both biological parents and all 4 grandparents of Japanese descent
- •Have a negative polymerase chain reaction test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on Day -1
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, any diagnostic agents to be administered during the study
- •History of, or positive test result at Screening for, human immunodeficiency virus
- •History of hepatitis C infection or positive test result at Screening for hepatitis C virus antibody
- •Symptoms consistent with SARS-CoV-2 infection, per the judgment of the Investigator, within 14 days prior to Day -1, including but not limited to fever (temperature > 37.5 degrees Celsius [°C]), sore throat, new and persistent cough, shortness of breath, diarrhea, muscle aches, or loss of taste or smell
- •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
- •Any immunization or vaccination given within 10 days prior to administration of study treatment and for 10 days after administration of study treatment
- •Mini mental state examination score of < 27 at Screening
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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: Predose and at multiple time points post-dose up to Day 99
次要结局
- Area Under the Concentration-Time Curve From Time 0 to Time of the Last Measurable Concentration (AUClast) of Aducanumab(Predose and at multiple time points post-dose up to Day 99)
- Number of Participants with Clinically Significant Abnormal Vital Sign Values(Up to Day 99)
- Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to Day 99)
- Area Under the Concentration-Time Curve From Time 0 to 4 Weeks (AUC0-4wk) of Aducanumab(Predose and at multiple time points post-dose up to Day 28)
- Elimination Half-Life (t1/2) of Aducanumab(Predose and at multiple time points post-dose up to Day 99)
- Number of Participants with Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Values(Day 1 and Day 99)
- Number of Participants with Clinically Significant Abnormal Laboratory Values(Up to Day 99)
- Maximum Observed Concentration (Cmax) of Aducanumab(Predose and at multiple time points post-dose up to Day 99)
- Time to Reach Maximum Observed Concentration (Tmax) for Aducanumab Administered SC(Predose and at multiple time points post-dose up to Day 99)
- Volume of Distribution (Vd) or Apparent Volume of Distribution (V/F) of Aducanumab(Predose and at multiple time points post-dose up to Day 99)
- Clearance (CL) or Apparent Clearance (CL/F) of Aducanumab(Predose and at multiple time points post-dose up to Day 99)
研究者
研究点 (6)
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