JPRN-jRCT2080224616已完成1 期
A Phase I Clinical Study of RO7105705 in Japanese Male Healthy Volunteers and Patients with Alzheimer's Disease
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
This study showed the safety of a single dose of 2100 to 16800 mg of RO7105705 in Japanese healthy adult males and multiple doses of 8100 mg in Japanese patients with mild-to-moderate AD. The pharmacokinetic linearity of this drug was confirmed in a single dose from 2100 to 16800 mg. ADA was not detected in all subjects.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 50age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •< Male HV and Patients with AD >
- •- Body weight between 40 kg and 100 kg, inclusive, at screening
- •< Male HV only >
- •- Aged between 20 and 60 years, inclusive
- •< Patients with AD only >
- •- Aged between 50 and 80 years, inclusive
- •- Diagnosis of probable AD dementia based on National Institute on Aging-Alzheimer's Association (NIA-AA) diagnostic criteria
- •- Screening MMSE score of 16 to 28 points
- •- Evidence of AD pathology as indicated by brain amyloid accumulation determined by quantitative determination of Abeta 42 concentration in CSF
排除标准
- •< Male HV and Patients with AD >
- •- Prior treatment with any other anti-tau antibody
- •- History or presence of a neurologic disease other than AD that may affect cognitive function
- •< Patients with AD only >
- •- Abnormal findings on brain MRI at screening
研究者
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