NCT07468708 The Dosimetry, Safety and Diagnostic Efficacy of ⁶⁸Ga-FC516 in Healthy Subjects and Patients With Prostate Cancer
| NCT ID | NCT07468708 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | FindCure Biosciences (ZhongShan) Co., Ltd. |
| Condition | Healthy Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2026-03-09 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2026-03-09 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Voluntarily participate the clinical study; sign the informed consent form; 2. Aged 18 years or older; 3. Cohort A: Healthy subjects; 4. Cohort B: Patients with prostate cancer confirmed by histopathological or cytological diagnosis; Exclusion Criteria: 1. Severe impairment of liver, kidney, or cardiac function; 2. Severe obesity or other conditions that prevent or make PET/CT scanning impossible; 3. Hypersensitivity to any active or inactive components of the study drug; 4. Other subjects deemed unsuitable for enrollment by the investigators.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07468708 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Healthy Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07468708 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07468708 currently recruiting?
Yes, NCT07468708 is actively recruiting participants. Contact the research team at wangtingjin@find-cure.com for enrollment information.
Where is the NCT07468708 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07468708 clinical trial?
NCT07468708 is sponsored by FindCure Biosciences (ZhongShan) Co., Ltd.. The trial plans to enroll 10 participants.