RecruitingEarly Phase 1

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

China10 participantsStarted 2026-03-09

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

Who can participate

Age range18 Years

SexMALE

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Inclusion criteria

✓. 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;

Exclusion criteria

✕. 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.

What they're measuring

Frequency of adverse events (AEs) and SAEs

Timeframe: Approximately 6 months

Standard uptake value (SUV) of tumors

Timeframe: Approximately 6 months

Human dosimetry

Timeframe: Approximately six months

Trial details

NCT IDNCT07468708

SponsorFindCure Biosciences (ZhongShan) Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07

Contact for this trial

Tingjin Wang

18664044814 wangtingjin@find-cure.com

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