A Phase I Clinical Study on the Safety and Pharmacokinetics of [18F]Florbetazine Injection

NCT06593626 | Completed Phase 1

• 1 other identifier: YZGK-FBZ-Ι-001
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a phase-1 study that aims to evaluate the safety and pharmacokinetics of \[18F\]Florbetazine injection in healthy subjects and patients with MCI and AD. This study has evaluated and compared the distributed patterns of \[18F\]Florbetazine injection in healthy subjects and patients with AD and MCI.

Conditions

MCI; AD

Keywords

18F; MCI; AD; phase Ⅰ

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability: Adverse events (AE) and their incidence during the trial,

  Safety and tolerability: Adverse events (AE) and their incidence during the trial, clinical symptoms and signs (including vital signs), laboratory findings.

  30 day

Secondary Outcomes (3)

• Standard uptake value ratio

  The whole process from collection to follow-up trial was completed

• Bio-distribution

  The whole process from collection to follow-up trial was completed

• Multi-dose exploration

  The whole process from collection to follow-up trial was completed

Study Arms (2)

[18F]Florbetazine, 10mCi

EXPERIMENTAL

Evaluate the safety and pharmacokinetics of \[18F\]Florbetazine injection in healthy subjects.

Drug: [18F]Florbetazine

[18F]Florbetazine, 10mCi, 8mCi, 5mCi

EXPERIMENTAL

AD and MCI

Drug: [18F]Florbetazine

Interventions

[18F]Florbetazine DRUG

Evaluate the safety of \[18F\]Florbetazine injection in AD and MCI patients, and healthy subjects.

[18F]Florbetazine, 10mCi; [18F]Florbetazine, 10mCi, 8mCi, 5mCi

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For all subjects
• Male and Female subjects aged 50-85 years (including 50 ang 85 years);
• Fertile men or women must use effective birth control during the study period (effective contraception means sterilization, intrauterine hormonal devices, condoms, contraceptives/pills, abstinence or excision vas deferens, etc.) For healthy subjects
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• Sign informed consent;
• Good health status or no major diseases are judged by the researcher based on the following assessments: medical history, health results of vital signs, physical examination, clinical electrocardiogram and clinical laboratory examination;
• Normal blood routine, blood biochemistry, urine routine and coagulation routine during the screening period, or abnormal without clinical significance;
• According to neuropsychological tests and researchers' judgment, no cognitive impairment;
• The score of clinical dementia rating (CDR) is 0;
• The score of mini-mental state examination (MMSE) is equal or greater than 27; For MCI patients
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• Sign informed consent;
• Diagnosed as Alzheimer's disease-related mild cognitive impairment (AD-MCI) according to the diagnostic criteria of NIA-AA;
• The Aβ-PET imaging displays positive result;
• The score of clinical dementia rating (CDR) is 0.5;

You may not qualify if:

• For all subjects
• Pregnant (positive pregnancy test during screening) or breastfeeding women;
• A history of alcohol or drug abuse/dependence;
• Known allergies to radiation and alcohol, or other severe allergies;
• Human immunodeficiency virus (HIV), hepatitis C virus (HCV) or treponema pallidum antibody test positive, hepatitis B virus (HBV) surface antigen positive;
• A history of liver disease or other conditions that interfere with drug absorption, distribution, excretion, or metabolism as determined by the investigator;
• Blood clotting history or blood clotting disorder;
• The present presence of clinically significant mental illness based on medical history, especially the present presence of major depression or schizophrenia;
• A history of epilepsy or convulsions, but not febrile convulsions in childhood;
• Significant occupational exposure to ionizing radiation (e.g., more than 50 MSV/year) within the past 10 years;
• Unable to repeat venipuncture;
• Have had metal devices implanted that are not compatible with MR, including pacemakers or defibrillators, insulin pumps, cochlear implants, intraocular metal implants, nerve stimulators, CNS aneurysm clips, etc., or have claustrophobia or cannot tolerate imaging procedures for other reasons;
• received any drug or treatment before enrollment that the investigator determines may interfere with the trial data or may cause serious side effects and is not fully eluted;
• Participating in other drug clinical studies and using other investigational drugs within 30 days prior to screening;
• Subjects received radiopharmaceutical imaging or treatment within 7 days prior to screening;

Sponsors & Collaborators

• HTA Co., Ltd.: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Related Publications (1)

• Li Y, Pan M, Yu H, Zhang Q, Chang Y, Zhao H, Wang J, Wang X, Dai J, Yu L, Chen D, Zhang J, Yan XX, Yao S, Cui M. Preclinical and preliminary clinical evaluation of [18F]Florbetazine for non-invasive PET detection of cardiac amyloidosis. Eur J Nucl Med Mol Imaging. 2026 Jan 10. doi: 10.1007/s00259-025-07719-9. Online ahead of print.

  PMID: 41518400 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-center, multi-dose, open-dosing study

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: September 19, 2024
• Study Start: November 6, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 10, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)