A Phase I Study of [18F]Flortaucipir PET Imaging in Chinese Subjects: Safety, Pharmacokinetics, Biodistribution, Radiation Dosimetry, and Preliminary Diagnostic Efficacy
11 de maio de 2026 atualizado por: 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).
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
18
Estágio
- Fase 1
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100853
- Recrutamento
- Chinese PLA General Hospital
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Contato:
- Dr. Wang Ruimin, Doctor
- Número de telefone: 86-13501151740
- E-mail: wrm@yeah.net
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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).
Outros nomes:
|
|
Experimental: 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).
Outros nomes:
|
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Experimental: AD (Alzheimer's disease)
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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).
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
Prazo: 6 days post-injection
|
6 days post-injection
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) - Total Radioactivity and Parent Compound
Prazo: 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
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Up to 360 mins
|
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Time to Reach Cmax (Tmax) - Total Radioactivity and Parent Compound
Prazo: 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
|
|
Terminal Half-Life (t½) of Unmetabolized Parent Compound
Prazo: Up to 360 mins
|
Up to 360 mins
|
|
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Area Under the Plasma Concentration-Time Curve (AUC0-t and AUC0-∞) of Unmetabolized Parent Compound
Prazo: 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.
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Up to 360 mins
|
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Percentage of Unmetabolized Parent Compound in Plasma
Prazo: Up to 360 mins
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Up to 360 mins
|
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Urinary Radioactive Excretion Rate
Prazo: 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
Prazo: 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
Prazo: Up to 360 mins post-injection
|
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)
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
23 de abril de 2026
Conclusão Primária (Estimado)
31 de dezembro de 2026
Conclusão do estudo (Estimado)
31 de março de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
26 de abril de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
5 de maio de 2026
Primeira postagem (Real)
12 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
14 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
11 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ELI-101-001
Informações sobre medicamentos e dispositivos, documentos de estudo
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Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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produto fabricado e exportado dos EUA
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