NCT07468708

The Dosimetry, Safety and Diagnostic Efficacy of ⁶⁸Ga-FC516 in Healthy Subjects and Patients With Prostate Cancer

Evaluation of Dosimetry, Safety, Biodistribution and Preliminary Diagnostic Efficacy of ⁶⁸Ga-FC516 in Healthy Subjects and Patients With Prostate Cancer

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: FindCure Biosciences (ZhongShan) Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This goal of this study is to investigate the dosimetry, safety, biodistribution of ⁶⁸Ga-FC516. In this study, we will evaluate the safety, biodistribution and dosimetry of ⁶⁸Ga-FC516 in subjects and compared them with the results of ⁶⁸Ga-labeled PSMA-targeting tracer or ⁶⁸Ga-labeled ACP3-targeting tracer imaging to evaluate the dosimetric characteristics and diagnostic efficacy of ⁶⁸Ga-FC516.

Conditions

• Healthy Adult
• Prostate Cancer

Interventions

Type	Name	Description
DRUG	⁶⁸Ga-FC516	Healthy subjects will receive ⁶⁸Ga-FC516 injection followed by PET/CT scans at multiple timepoints post-administration.
DRUG	⁶⁸Ga-FC516 and ⁶⁸Ga-labeled PSMA-targeting tracer	Patients with prostate cancer will undergo both ⁶⁸Ga-FC516 and ⁶⁸Ga-labeled PSMA-targeting tracer PET/CT scans with a minimum interval of 24 hours and a maximum of 14 days between the two.
DRUG	⁶⁸Ga-FC516 and ⁶⁸Ga-labeled ACP3-targeting tracer	Patients with prostate cancer will undergo both ⁶⁸Ga-FC516 and ⁶⁸Ga-labeled ACP3-targeting tracer PET/CT scans with a minimum interval of 24 hours and a maximum of 14 days between the two.

Timeline

• Start date: 2026-03-09
• Primary completion: 2026-07-01
• Completion: 2026-08-01
• First posted: 2026-03-12
• Last updated: 2026-04-17

Locations

1 site across 1 country: China