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A Phase I Study of [18F]Flortaucipir PET Imaging in Chinese Subjects: Safety, Pharmacokinetics, Biodistribution, Radiation Dosimetry, and Preliminary Diagnostic Efficacy

11. maj 2026 opdateret af: 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).

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

18

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100853
        • Rekruttering
        • Chinese PLA General Hospital
        • Kontakt:
          • Dr. Wang Ruimin, Doctor
          • Telefonnummer: 86-13501151740
          • E-mail: wrm@yeah.net

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde 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:

    1. CN: No history of cognitive impairment, Aβ-PET negative, MRI without clinically significant neurodegenerative changes.
    2. MCI: Meet core criteria for AD-related MCI, Aβ-PET positive, MRI showing neurodegenerative changes.
    3. 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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: CN (cognitively normal)
Medicin: [18F]Flortaucipir Injection
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 navne:
  • ELI-101
Eksperimentel: MCI (mild cognitive impairment)
Medicin: [18F]Flortaucipir Injection
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 navne:
  • ELI-101
Eksperimentel: AD (Alzheimer's disease)
Medicin: [18F]Flortaucipir Injection
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 navne:
  • ELI-101

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
Tidsramme: 6 days post-injection
6 days post-injection

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
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
Percentage of Unmetabolized Parent Compound in Plasma
Tidsramme: Up to 360 mins
Up to 360 mins
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
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.
Up to 360 mins post-injection
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
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
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
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).
Up to 240 mins post-injection
Effective Dose (Whole-Body)
Tidsramme: Up to 240 mins post-injection
Up to 240 mins post-injection
Visual Read Positivity Rate - Overall and by Subject Subgroup
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Eli Radiopharma

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

23. april 2026

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

31. marts 2027

Datoer for studieregistrering

Først indsendt

26. april 2026

Først indsendt, der opfyldte QC-kriterier

5. maj 2026

Først opslået (Faktiske)

12. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ELI-101-001

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med MCI

Kliniske forsøg med [18F]Flortaucipir Injection

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