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).
調査の概要
研究の種類
介入
入学 (推定)
18
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Beijing Municipality
-
Beijing、Beijing Municipality、中国、100853
- 募集
- Chinese PLA General Hospital
-
コンタクト：
- Dr. Wang Ruimin, Doctor
- 電話番号：86-13501151740
- メール：wrm@yeah.net
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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).
他の名前：
|
|
実験的：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).
他の名前：
|
|
実験的：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).
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
時間枠：6 days post-injection
|
6 days post-injection
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) - Total Radioactivity and Parent Compound
時間枠：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
|
|
Time to Reach Cmax (Tmax) - Total Radioactivity and Parent Compound
時間枠：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.
|
Up to 360 mins
|
|
Terminal Half-Life (t½) of Unmetabolized Parent Compound
時間枠：Up to 360 mins
|
Up to 360 mins
|
|
|
Area Under the Plasma Concentration-Time Curve (AUC0-t and AUC0-∞) of Unmetabolized Parent Compound
時間枠：Up to 360 mins
|
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.
|
Up to 360 mins
|
|
Percentage of Unmetabolized Parent Compound in Plasma
時間枠：Up to 360 mins
|
Up to 360 mins
|
|
|
Urinary Radioactive Excretion Rate
時間枠：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
|
|
Cumulative Urinary Excretion of Radioactivity
時間枠：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
|
|
Percentage of Unmetabolized Parent Compound and Metabolites in Urine
時間枠：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)
時間枠：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
|
|
Mean Standardized Uptake Value (SUVmean) in Target Organs/Tissues
時間枠：Up to 240 mins post-injection
|
SUVmean is defined as the mean tissue radioactivity concentration (decay-corrected) normalized by injected dose per body weight.
|
Up to 240 mins post-injection
|
|
Residence Time (Source Organ Time-Integrated Activity)
時間枠：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
|
|
Absorbed Dose to Target Organs/Tissues
時間枠：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).
|
Up to 240 mins post-injection
|
|
Effective Dose (Whole-Body)
時間枠：Up to 240 mins post-injection
|
Up to 240 mins post-injection
|
|
|
Visual Read Positivity Rate - Overall and by Subject Subgroup
時間枠：At 80 mins post-injection
|
Proportion of subjects with a positive PET scan based on visual assessment (blinded, independent readers) using a predefined read criterion
|
At 80 mins post-injection
|
|
Standardized Uptake Value Ratio (SUVR) - Composite Region
時間枠：At 80 mins post-injection
|
SUVR is calculated as the mean standardized uptake value (SUV) in a composite target region of interest
|
At 80 mins post-injection
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年4月23日
一次修了 (推定)
2026年12月31日
研究の完了 (推定)
2027年3月31日
試験登録日
最初に提出
2026年4月26日
QC基準を満たした最初の提出物
2026年5月5日
最初の投稿 (実際)
2026年5月12日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月14日
QC基準を満たした最後の更新が送信されました
2026年5月11日
最終確認日
2026年5月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。