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

No results posted yet for this study

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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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06593626 on ClinicalTrials.gov