NCT07580703RecruitingPhase 1
A Phase I Study of [18F]Flortaucipir PET Imaging in Chinese Subjects: Safety, Pharmacokinetics, Biodistribution, Radiation Dosimetry, and Preliminary Diagnostic Efficacy
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
Source: ClinicalTrials.gov · Last updated 14 May 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- First submitted
- 26 Apr 2026
- Start date
- 23 Apr 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Eli Radiopharma
- Diseases
- Alzheimer disease
- NCT number
- NCT07580703
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 18
- From 23 Apr 2026 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Major surgery within 1 month prior to screening, or planned surgery during the study period.
Other illness
- 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).
- 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.
Other
- Pregnant (positive pregnancy test at screening or before administration) or breastfeeding women.
- Inability to tolerate PET/MRI or presence of contraindications to PET/MRI.
Who the study is looking for
- 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).
Age in the registry: 50 years to 85 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chinese PLA General Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.