A Phase I Study of [18F]Flortaucipir PET Imaging in Chinese Subjects: Safety, Pharmacokinetics, Biodistribution, Radiation Dosimetry, and Preliminary Diagnostic Efficacy
2026年5月11日 更新者：Eli Radiopharma
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
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).
研究概览
研究类型
介入性
注册 (估计的)
18
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Beijing Municipality
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Beijing、Beijing Municipality、中国、100853
- 招聘中
- Chinese PLA General Hospital
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接触：
- Dr. Wang Ruimin, Doctor
- 电话号码：86-13501151740
- 邮箱：wrm@yeah.net
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：CN (cognitively normal)
|
A radioactive diagnostic agent intended for brain positron emission tomography (PET) imaging in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD), to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs).
其他名称：
|
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实验性的：MCI (mild cognitive impairment)
|
A radioactive diagnostic agent intended for brain positron emission tomography (PET) imaging in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD), to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs).
其他名称：
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实验性的：AD (Alzheimer's disease)
|
A radioactive diagnostic agent intended for brain positron emission tomography (PET) imaging in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD), to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs).
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
大体时间：6 days post-injection
|
6 days post-injection
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) - Total Radioactivity and Parent Compound
大体时间：Up to 360 mins
|
Cmax is defined as the highest observed plasma concentration of total radioactivity (measured by gamma counting) and of the unmetabolized parent [18F]Flortaucipir
|
Up to 360 mins
|
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Time to Reach Cmax (Tmax) - Total Radioactivity and Parent Compound
大体时间：Up to 360 mins
|
Tmax is the time (in minutes) at which the maximum plasma concentration (Cmax) occurs, recorded as the midpoint of the sampling interval during which the maximum is observed.
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Up to 360 mins
|
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Terminal Half-Life (t½) of Unmetabolized Parent Compound
大体时间：Up to 360 mins
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Up to 360 mins
|
|
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Area Under the Plasma Concentration-Time Curve (AUC0-t and AUC0-∞) of Unmetabolized Parent Compound
大体时间：Up to 360 mins
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AUC0-t is calculated using the linear trapezoidal rule from time 0 to the last measurable concentration.
AUC0-∞ is extrapolated as AUC0-t + Ct/λz, where Ct is the last quantifiable concentration and λz is the terminal elimination rate constant.
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Up to 360 mins
|
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Percentage of Unmetabolized Parent Compound in Plasma
大体时间：Up to 360 mins
|
Up to 360 mins
|
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Urinary Radioactive Excretion Rate
大体时间：0-60, 60-120, 120-240, 240-360 mins post-injection
|
Rate of radioactivity excreted in urine, expressed as percentage of injected dose per hour (%ID/h).
Measured by gamma counting of collected urine aliquots over specified intervals.
|
0-60, 60-120, 120-240, 240-360 mins post-injection
|
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Cumulative Urinary Excretion of Radioactivity
大体时间：Up to 360 mins post-injection
|
Total cumulative percentage of the injected radioactive dose recovered in urine over time.
Calculated as the sum of radioactivity excreted at each collection interval.
|
Up to 360 mins post-injection
|
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Percentage of Unmetabolized Parent Compound and Metabolites in Urine
大体时间：Up to 360 mins post-injection
|
Relative proportion of total urinary radioactivity that corresponds to the intact [18F]Flortaucipir and its known radioactive metabolites.
|
Up to 360 mins post-injection
|
|
Organ/Tissue Radioactivity Uptake - Percent Injected Dose (%ID)
大体时间：Up to 240 mins post-injection
|
Percentage of the injected radioactive dose (%ID) present in each target organ or tissue (e.g., brain, liver, kidneys, lungs, bone marrow, etc.) at specified imaging time points.
|
Up to 240 mins post-injection
|
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Mean Standardized Uptake Value (SUVmean) in Target Organs/Tissues
大体时间：Up to 240 mins post-injection
|
SUVmean is defined as the mean tissue radioactivity concentration (decay-corrected) normalized by injected dose per body weight.
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Up to 240 mins post-injection
|
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Residence Time (Source Organ Time-Integrated Activity)
大体时间：Up to 240 mins post-injection
|
Residence time (also known as time-integrated activity coefficient) for each source organ, expressed as hours (or minutes).
|
Up to 240 mins post-injection
|
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Absorbed Dose to Target Organs/Tissues
大体时间：Up to 240 mins post-injection
|
Absorbed dose (mGy) to each target organ/tissue (e.g., brain, liver, kidneys, urinary bladder wall, lungs, red marrow, heart wall, spleen, thyroid, etc.) per unit administered activity (mGy/MBq).
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Up to 240 mins post-injection
|
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Effective Dose (Whole-Body)
大体时间：Up to 240 mins post-injection
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Up to 240 mins post-injection
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Visual Read Positivity Rate - Overall and by Subject Subgroup
大体时间：At 80 mins post-injection
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Proportion of subjects with a positive PET scan based on visual assessment (blinded, independent readers) using a predefined read criterion
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At 80 mins post-injection
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Standardized Uptake Value Ratio (SUVR) - Composite Region
大体时间：At 80 mins post-injection
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SUVR is calculated as the mean standardized uptake value (SUV) in a composite target region of interest
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At 80 mins post-injection
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年4月23日
初级完成 (估计的)
2026年12月31日
研究完成 (估计的)
2027年3月31日
研究注册日期
首次提交
2026年4月26日
首先提交符合 QC 标准的
2026年5月5日
首次发布 (实际的)
2026年5月12日
研究记录更新
最后更新发布 (实际的)
2026年5月14日
上次提交的符合 QC 标准的更新
2026年5月11日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.