NCT06593626

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

A Phase I Clinical Study on the Safety and Pharmacokinetics of [18F]Florbetazine Injection in Healthy Subjects and Patients With Amyloid Fibrils

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: HTA Co., Ltd. · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Accepted

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

Interventions

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

Timeline

• Start date: 2023-11-06
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2024-09-19
• Last updated: 2025-07-10

Locations

1 site across 1 country: China