A Phase 2, Open-Label Study of AMDX-2011P as a Retinal Tracer in Participants With Cerebral Amyloid Angiopathy (CAA)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Amydis Inc.
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- AMDX-2011P Adverse Events Profile
研究概览
简要总结
The purpose of this study is to assess safety, tolerability, plasma pharmacokinetics and biologic activity of a single intravenous dose of AMDX-2011P in participants with cerebral amyloid angiopathy (CAA).
详细描述
This open-label, masked endpoint assessment study will evaluate the safety, tolerability, plasma pharmacokinetics (PK) and biological activity of an intravenous (IV) dose of AMDX-2011P in participants with CAA. Assessments of retinal images will be conducted by central masked assessors.
Participants will be admitted to the study site where eye examination and retinal imaging will be conducted before administration of the study drug. AMDX-2011P will be administered through a single IV bolus injection followed by safety assessments, retinal imaging and PK blood collection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of hereditary CAA or probable and definite symptomatic or asymptomatic sporadic CAA diagnosed through genetic testing or according to the modified Boston neuroradiological criteria, who had undergone at least one brain magnetic resonance imaging (MRI)prior to entry into study.
- •Abnormality consistent with CAA on historical MRI.
- •In general good health
排除标准
- •Presence of any underlying physical or psychological medical condition that, in the opinion of the investigator, would make it unlikely that the participant will complete the study per protocol.
- •Clinically significant laboratory abnormalities assessed by the investigator.
- •Active malignancy and/or history of malignancy in the past 5 years, with the exception of completely excised non-melanoma skin cancer or low-grade cervical intraepithelial neoplasia.
- •Prolonged QTcF (>450 ms for males and >470 ms for females),cardiac arrhythmia, or any clinically significant abnormality in the resting ECG, as judged by the investigator.
研究组 & 干预措施
AMDX-2011P 100 mg
AMDX2011P 100mg (4ml) single bolus injection intravenous for diagnostic review
干预措施: AMDX-2011P (Drug)
结局指标
主要结局
AMDX-2011P Adverse Events Profile
时间窗: 8 days
Incidence, nature and severity of AEs/SAEs
次要结局
- Pharmacokinetic Analysis of AMDX-2011P(2 hours)
- Concentration of AMDX-2011P(2 hours)
- Biological Activity(8 days)