NCT07580703招募中1 期
A Non Randomized, Open-Label Phase I Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Biodistribution and Radiation Dosimetry, and Preliminary Diagnostic Efficacy of [18F]Flortaucipir Injection PET Imaging in Chinese Subjects
Eli Radiopharma1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2026年4月23日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 18
- 试验地点
- 1
研究概览
简要总结
This is a non randomized, open-label Phase I study in Chinese participants. The goal of this clinical trial is to evaluate the safety and tolerability of a radioactive imaging agent called [18F]Flortaucipir Injection, which is used during a PET scan. The study will also measure how the agent moves through the body (pharmacokinetics), where it goes (biodistribution), the amount of radiation exposure (radiation dosimetry), and how well it may help detect signs of disease (preliminary diagnostic efficacy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent form (ICF).
- •Male or female aged 50-85 years.
- •Education level sufficient to cooperate with neuropsychological testing and obtain reliable results.
- •Meet the following criteria related to cognitive impairment:
- •CN: No history of cognitive impairment, Aβ-PET negative, MRI without clinically significant neurodegenerative changes.
- •MCI: Meet core criteria for AD-related MCI, Aβ-PET positive, MRI showing neurodegenerative changes.
- •AD: Meet core criteria for probable AD dementia, Aβ-PET positive, MRI showing neurodegenerative changes.
- •Fertile individuals: No plan for reproduction, sperm/egg donation within 6 months after signing ICF and until 6 months after study drug administration; and agreement to use highly effective contraception (including partner).
排除标准
- •Pregnant (positive pregnancy test at screening or before administration) or breastfeeding women.
- •Major surgery within 1 month prior to screening, or planned surgery during the study period.
- •Known allergy to radioactive radiation, alcohol, [18F]Flortaucipir injection, or its excipients, or other severe allergic reactions.
- •Cognitive impairment due to causes other than AD.
- •Clinically significant infarction or probable multi-infarct dementia.
- •Current clinically significant psychiatric illness (e.g., major depression, schizophrenia).
- •History of epilepsy or seizures (except febrile seizures in childhood).
- •Inability to tolerate PET/MRI or presence of contraindications to PET/MRI.
- •Other neurodegenerative diseases or dementias other than AD dementia.
- •Any other condition that, in the investigator's opinion, makes the subject unsuitable for the study.
研究者
研究点 (1)
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