A Single-Center, Randomized, Investigator/Subject-Blind Single-Ascending Dose, Placebo-Controlled, Parallel Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Gantenerumab Following SC Administration in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Percentage of participants with adverse events (AEs)
研究概览
简要总结
This two-part study is designed to assess the safety, tolerability, and PK of gantenerumab in healthy volunteers. Part I (dose escalation) will randomly assign participants to receive a single blinded SC dose of gantenerumab or placebo. Part II (PK extension) will randomly assign participants to receive a single open-label SC dose of ganenerumab at different dose levels according to safety assessments from Part I.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy males 18 to 45 years of age, inclusive
- •Body mass index (BMI) 20.0 to 32.0 kilograms per meter-squared (kg/m^2), inclusive
排除标准
- •History of cancer or any clinically significant disease affecting one of the major organ systems
- •Prior administration of gantenerumab
- •Clinically significant laboratory test results
- •Clinically relevant history of hypersensitivity or allergic reaction following exposure to a drug, food, or environmental agent
- •Known hypersensitivity to gantenerumab or excipients of study drug formulation
- •Abnormal skin condition or potentially obscuring tattoo, pigmentation, or lesion in the area intended for SC injection
- •Familial history of early-onset Alzheimer's disease
研究组 & 干预措施
Part I (Dose Escalation): Gantenerumab
Participants will receive a single SC dose of gantenerumab on Day 1.
干预措施: Gantenerumab (Drug)
Part I (Dose Escalation): Placebo
Participants will receive a single SC dose of matching placebo on Day 1.
干预措施: Placebo (Drug)
Part II (PK Extension): Gantenerumab
Participants will receive a single SC dose of gantenerumab on Day 1. The dose range will be determined by safety and tolerability data collected from Part I.
干预措施: Gantenerumab (Drug)
结局指标
主要结局
Percentage of participants with adverse events (AEs)
时间窗: Up to 12 weeks (from Baseline to Day 85 +/- 5 days)
次要结局
- Area under the plasma concentration-time curve (AUC) of gantenerumab(Predose (0 hours) and 1, 6, and 12 hours from single dose administration; once daily from Days 2 to 10; and once daily on Days 12, 15, 21, 29, 43, 64, and 85)
- Maximum observed plasma concentration (Cmax) of gantenerumab(Predose (0 hours) and 1, 6, and 12 hours from single dose administration; once daily from Days 2 to 10; and once daily on Days 12, 15, 21, 29, 43, 64, and 85)