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

Recruiting now · Early Phase 1

Conditions studied: Healthy Adult, Prostate Cancer

In brief

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 prostate cancer-targeting tracer imaging to evaluate the dosimetric characteristics and diagnostic efficacy of ⁶⁸Ga-FC516.

Key facts

Study ID

NCT07468708

Run by

FindCure Biosciences (ZhongShan) Co., Ltd.

People needed

10

Starts

2026-03-09

Expected to finish

2026-08-01

Last updated by the study team

2026-04-29

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Voluntarily participate the clinical study; sign the informed consent form;
• Aged 18 years or older;
• Cohort A: Healthy subjects;
• Cohort B: Patients with prostate cancer confirmed by histopathological or cytological diagnosis;

You may not qualify if…

• Severe impairment of liver, kidney, or cardiac function;
• Severe obesity or other conditions that prevent or make PET/CT scanning impossible;
• Hypersensitivity to any active or inactive components of the study drug;
• Other subjects deemed unsuitable for enrollment by the investigators.

Where it is running

• The first affiliated hospital of Jinan University — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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