NCT02133937已完成1 期
A Single-center, Randomized Open-label, Single-dose, Parallel Group Study to Investigate the Relative Bioavailability of a High Concentration Liquid Formulation (Hclf) in Prefilled Syringes Versus the Reference Lyophilized Formulation (Lyof) of Gantenerumab Following Administration by Subcutaneous Injection in Healthy Volunteers
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
- 31
- 主要终点
- Plasma concentration of gantenerumab
研究概览
简要总结
This single-center, randomized open-label, single-dose, parallel group study will investigate the relative bioavailability of a high concentration liquid formulation (HCLF) versus the reference lyophilized formulation (LyoF) of gantenerumab. Healthy volunteers will be randomized 1:1 to receive single-dose gantenerumab by subcutaneous injection.
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
- •Healthy male and female subjects, 40 to 70 years of age inclusive. Healthy status is defined by absence of evidence any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, coagulation, serology and urinalysis. Some medical conditions are allowed that are well controlled by single stable medication
- •A BMI between 18.0 to 30.0 kg/m2 inclusive
- •Use of highly effective contraception until 6 months after study follow-up visit
- •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 abuse addiction using DSM IV criteria
- •Regular smoker (> 5 cigarettes, > 1 pipeful or > 1 cigar per day), tobacco users and subjects on nicotine replacement therapy
- •Prior administration of gantenerumab
- •Participation in an investigational drug or device study within 60 days before dosing
- •Donation of blood over 500 mL within three months before dosing
- •Pregnancy or breast-feeding
- •Any abnormal skin conditions or potentially obscuring tattoos, pigmentation or lesions in the area intended for subcutaneous injection
- •Any familial history of early onset Alzheimer's disease
- •Claustrophobia, presence of pacemakers, aneurysm 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
High Concentration Liquid Formulation (HCLF)
Experimental
干预措施: gantenerumab (Drug)
Lyophilized formulation
Active Comparator
干预措施: gantenerumab (Drug)
结局指标
主要结局
Plasma concentration of gantenerumab
时间窗: Up to 13 weeks
次要结局
- Incidence of adverse events(Approximately 21 weeks)
研究者
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