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

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).

Study Overview

• Status: Recruiting
• Conditions: MCI; AD - Alzheimer's Disease
• Intervention / Treatment: Drug: [18F]Flortaucipir Injection

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100853
      • Recruiting
      • Chinese PLA General Hospital
      • Contact: Dr. Wang Ruimin, Doctor; Phone Number: 86-13501151740; Email: wrm@yeah.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CN (cognitively normal)	Drug: [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).; Other Names: ELI-101
Experimental: MCI (mild cognitive impairment)	Drug: [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).; Other Names: ELI-101
Experimental: AD (Alzheimer's disease)	Drug: [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).; Other Names: ELI-101

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)	6 days post-injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Plasma Concentration (Cmax) - Total Radioactivity and Parent Compound	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	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		Up to 360 mins
Area Under the Plasma Concentration-Time Curve (AUC0-t and AUC0-∞) of Unmetabolized Parent Compound	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		Up to 360 mins
Urinary Radioactive Excretion Rate	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	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	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)	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	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)	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	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)		Up to 240 mins post-injection
Visual Read Positivity Rate - Overall and by Subject Subgroup	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	SUVR is calculated as the mean standardized uptake value (SUV) in a composite target region of interest	At 80 mins post-injection

Collaborators and Investigators

• Sponsor: Eli Radiopharma

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: April 26, 2026
• First Submitted That Met QC Criteria: May 5, 2026
• First Posted (Actual): May 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Alzheimer's disease; MCI; Phase I; AD; tau-PET; [18F]Flortaucipir; ELI-101; ELI-101-001
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease; 7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole
• Other Study ID Numbers: ELI-101-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No