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

Phase 1 Completed 28 enrolled HTA Co., Ltd.

Non-randomizedSingle-groupOpen-labelDiagnostic

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.

Timeline

Start: 2023-11-06
Primary completion: 2025-06-30
Completion: 2025-06-30

Publications

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 Apr;53(5):3364-3374. doi: 10.1007/s00259-025-07719-9. Epub 2026 Jan 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Florbetazine	Diagnostic / imaging agent	185 mbq	—
Subject	Florbetazine	Diagnostic / imaging agent	296 mbq	—
Subject	Florbetazine	Diagnostic / imaging agent	370 mbq	—

Indications

No indication recorded.