NCT01636531已完成1 期
A Multi-center, Randomized Open-label, Single-dose, Parallel Group Investigation of the Relative Bioavailability, Tolerability and Dose-exposure Relationship of a High Concentration Liquid Formulation (HCLF) Versus a Lyophilized Formulation (LyoF) of RO4909832 (Gantenerumab) When Administered by su
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 120
- 主要终点
- Relative bioavailability: Area under the concentration-time curve
研究概览
简要总结
This multi-center, randomized, open-label, single-dose, parallel group study will assess the relative bioavailability, tolerability and dose-exposure relationship of a high concentration liquid formulation (HCLF) versus a lyophilized formulation (LyoF) of gantenerumab (RO4909832) in healthy volunteers. Subjects will be randomized to receive single subcutaneous doses of either HCLF or LyoF. Anticipated time for treatment period and follow-up will be 13 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Healthy male and female subjects, 40 to 70 years of age. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination
- •Body mass index 18.0 to 30.0 kg/m2 inclusive
- •Female subjects who are either surgically sterilized or post-menopausal
- •Agree not to donate blood or blood products for transfusion for the duration of the study and for one year after their dosing
排除标准
- •Suspicion of alcohol or drugs of abuse addiction
- •Positive for hepatitis B, hepatitis C or HIV 1 or 2 infection
- •Participation in an investigational drug or device study within three months before dosing
- •Concomitant disease or condition or treatment which could interfere with the conduct of the study or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
- •Any clinically relevant history of hypersensitivity or allergic reactions, either spontaneous or following drug administration or exposure to food or environmental agents
- •Any familial history of early onset Alzheimer's disease
- •Claustrophobia, presence of pacemakers, aneurism clips, artificial heart valves, ear implants, or foreign metal objects in the eyes, skin or body which would contraindicate an MRI scan
研究组 & 干预措施
HCLF
Experimental
干预措施: gantenerumab (Drug)
LyoF
Active Comparator
干预措施: gantenerumab (Drug)
结局指标
主要结局
Relative bioavailability: Area under the concentration-time curve
时间窗: Pre-dose and up to 85 days post-dose
次要结局
- Dose-exposure relationship(approximately 8 months)
- Safety: Incidence of adverse events(approximately 8 months)
研究者
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