A Phase I Clinical Study on the Safety and Pharmacokinetics of [18F]Florbetazine Injection
NCT06593626 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2025-07-10
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
Interventions
- DRUG
-
[18F]Florbetazine
Evaluate the safety of \[18F\]Florbetazine injection in AD and MCI patients, and healthy subjects.
Sponsors & Collaborators
-
HTA Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 50 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-11-06
- Primary Completion
- 2025-06-30
- Completion
- 2025-06-30
Countries
- China
Study Locations
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