A Phase I Study of [18F]Flortaucipir PET Imaging in Chinese Subjects: Safety, Pharmacokinetics, Biodistribution, Radiation Dosimetry, and Preliminary Diagnostic Efficacy
11. mai 2026 oppdatert av: 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).
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
18
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Kina, 100853
- Rekruttering
- Chinese PLA General Hospital
-
Ta kontakt med:
- Dr. Wang Ruimin, Doctor
- Telefonnummer: 86-13501151740
- E-post: wrm@yeah.net
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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).
Andre navn:
|
|
Eksperimentell: 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).
Andre navn:
|
|
Eksperimentell: 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).
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
Tidsramme: 6 days post-injection
|
6 days post-injection
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) - Total Radioactivity and Parent Compound
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
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Percentage of Unmetabolized Parent Compound in Plasma
Tidsramme: Up to 360 mins
|
Up to 360 mins
|
|
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Urinary Radioactive Excretion Rate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
|
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Residence Time (Source Organ Time-Integrated Activity)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: Up to 240 mins post-injection
|
Up to 240 mins post-injection
|
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Visual Read Positivity Rate - Overall and by Subject Subgroup
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
23. april 2026
Primær fullføring (Antatt)
31. desember 2026
Studiet fullført (Antatt)
31. mars 2027
Datoer for studieregistrering
Først innsendt
26. april 2026
Først innsendt som oppfylte QC-kriteriene
5. mai 2026
Først lagt ut (Faktiske)
12. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ELI-101-001
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
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