A Phase I Study of [18F]Flortaucipir PET Imaging in Chinese Subjects: Safety, Pharmacokinetics, Biodistribution, Radiation Dosimetry, and Preliminary Diagnostic Efficacy
2026년 5월 11일 업데이트: 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).
연구 개요
연구 유형
중재적
등록 (추정된)
18
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Beijing Municipality
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Beijing, Beijing Municipality, 중국, 100853
- 모병
- Chinese PLA General Hospital
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연락하다:
- Dr. Wang Ruimin, Doctor
- 전화번호: 86-13501151740
- 이메일: wrm@yeah.net
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: CN (cognitively normal)
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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).
다른 이름들:
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실험적: MCI (mild cognitive impairment)
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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).
다른 이름들:
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실험적: 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).
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
기간: 6 days post-injection
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6 days post-injection
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Maximum Observed Plasma Concentration (Cmax) - Total Radioactivity and Parent Compound
기간: Up to 360 mins
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Cmax is defined as the highest observed plasma concentration of total radioactivity (measured by gamma counting) and of the unmetabolized parent [18F]Flortaucipir
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Up to 360 mins
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Time to Reach Cmax (Tmax) - Total Radioactivity and Parent Compound
기간: Up to 360 mins
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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
기간: 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
기간: 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
기간: Up to 360 mins
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Up to 360 mins
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Urinary Radioactive Excretion Rate
기간: 0-60, 60-120, 120-240, 240-360 mins post-injection
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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.
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0-60, 60-120, 120-240, 240-360 mins post-injection
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Cumulative Urinary Excretion of Radioactivity
기간: Up to 360 mins post-injection
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Total cumulative percentage of the injected radioactive dose recovered in urine over time.
Calculated as the sum of radioactivity excreted at each collection interval.
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Up to 360 mins post-injection
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Percentage of Unmetabolized Parent Compound and Metabolites in Urine
기간: Up to 360 mins post-injection
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Relative proportion of total urinary radioactivity that corresponds to the intact [18F]Flortaucipir and its known radioactive metabolites.
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Up to 360 mins post-injection
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Organ/Tissue Radioactivity Uptake - Percent Injected Dose (%ID)
기간: Up to 240 mins post-injection
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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.
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Up to 240 mins post-injection
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Mean Standardized Uptake Value (SUVmean) in Target Organs/Tissues
기간: Up to 240 mins post-injection
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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)
기간: Up to 240 mins post-injection
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Residence time (also known as time-integrated activity coefficient) for each source organ, expressed as hours (or minutes).
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Up to 240 mins post-injection
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Absorbed Dose to Target Organs/Tissues
기간: Up to 240 mins post-injection
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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)
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 4월 23일
기본 완료 (추정된)
2026년 12월 31일
연구 완료 (추정된)
2027년 3월 31일
연구 등록 날짜
최초 제출
2026년 4월 26일
QC 기준을 충족하는 최초 제출
2026년 5월 5일
처음 게시됨 (실제)
2026년 5월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 11일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- ELI-101-001
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
미국에서 제조되어 미국에서 수출되는 제품
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
MCI에 대한 임상 시험
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AccexibleFundación Universitaria Sanitas (UNISANITAS)완전한
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Xuanwu Hospital, Beijing아직 모집하지 않음
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University of California, San FranciscoNational Institute on Aging (NIA)모병
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University of PennsylvaniaNational Institutes of Health (NIH); National Institute on Aging (NIA)모집하지 않고 적극적으로
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Philips Electronics Nederland B.V. acting through...Qserve; Dent Neurologic Institute완전한
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Yuan ShenShanghai Mental Health Center아직 모집하지 않음MCI-AD, 초기 단계 알츠하이머병
[18F]Flortaucipir Injection에 대한 임상 시험
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Marmara University모병
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China Academy of Chinese Medical SciencesNational Natural Science Foundation of China모병
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Shanghai University of Traditional Chinese Medicine아직 모집하지 않음
-
Tharick PascoalNational Institute on Aging (NIA)모집하지 않고 적극적으로
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Shanghai University of Traditional Chinese Medicine알려지지 않은
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Biobizkaia Health Research InstituteRoche Farma, S.A모병