Healthy AdultEarly Phase 1NCT07468708
The Dosimetry, Safety and Diagnostic Efficacy of ⁶⁸Ga-FC516 in Healthy Subjects and Patients With Prostate Cancer
A Early Phase 1 study testing ⁶⁸Ga-FC516 and ⁶⁸Ga-FC516 and ⁶⁸Ga-labeled prostate cancer-targeting tracer in people with Healthy Adult and Prostate Cancer, run by FindCure Biosciences (ZhongShan) Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult, Prostate Cancer
- What is being tested?
- ⁶⁸Ga-FC516 and ⁶⁸Ga-FC516 and ⁶⁸Ga-labeled prostate cancer-targeting tracer
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 9 Mar 2026to Oct 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The first affiliated hospital of Jinan University
Guangzhou, Guangdong
Lu Wang, Doctor, 020-36868405, l_wang1009@foxmail.com
Lu Wang, Doctor
About this study
Official title: Evaluation of Dosimetry, Safety, Biodistribution and Preliminary Diagnostic Efficacy of ⁶⁸Ga-FC516 in Healthy Subjects and Patients With Prostate Cancer
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.
- Conditions
- Healthy Adult, Prostate Cancer
- Being tested
- ⁶⁸Ga-FC516, ⁶⁸Ga-FC516 and ⁶⁸Ga-labeled prostate cancer-targeting tracer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
⁶⁸Ga-FC516Drug
Healthy subjects will receive ⁶⁸Ga-FC516 injection followed by PET/CT scans at multiple timepoints post-administration.
⁶⁸Ga-FC516 and ⁶⁸Ga-labeled prostate cancer-targeting tracerDrug
Patients with prostate cancer will undergo both ⁶⁸Ga-FC516 and ⁶⁸Ga-labeled prostate cancer-targeting tracer PET/CT scans with a minimum interval of 24 hours and a maximum of 14 days between the two.
| Study group | Role | What they receive |
|---|---|---|
| ⁶⁸Ga-FC516 PET/CT | Experimental | Not described Receives: Drug: ⁶⁸Ga-FC516 |
| ⁶⁸Ga-FC516 and ⁶⁸Ga-labeled prostate cancer-targeting tracer PET/CT | Experimental | Not described Receives: Drug: ⁶⁸Ga-FC516 and ⁶⁸Ga-labeled prostate cancer-targeting tracer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of adverse events (AEs) and SAEs
Measured: Approximately 6 months
Standard uptake value (SUV) of tumors
Compare the SUV of tumor between 68Ga-FC516 PET/CT and 68Ga-labeled prostate cancer-targeting tracer PET/CT
Measured: Approximately 6 months
Human dosimetry
Radiation dose to individual organs and the equivalent dose for the whole body of each subject.
Measured: Approximately six months
Secondary outcomes (1)
Tumor detection rate
Compare the tumor detection rate between 68Ga-FC516 PET/CT and 68Ga-labeled prostate cancer-targeting tracer PET/CT.
Measured: Approximately six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start9 Mar 2026
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FindCure Biosciences (ZhongShan) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- First Affiliated Hospital of Jinan University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07468708
- Sponsor's protocol ID
- FC516-IIT-01
- Status last verified
- Sep 2026
- First submitted
- 9 Mar 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dosimetry, Safety, Biodistribution and Preliminary Diagnostic Efficacy of ⁶⁸Ga-FC516 in Healthy Subjects and Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT07468708
- Acronym / sponsor ID
- FC516-IIT-01
- Conditions
- Healthy Adult, Prostate Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- FindCure Biosciences (ZhongShan) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- First Affiliated Hospital of Jinan University
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ⁶⁸Ga-FC516 PET/CT | Experimental | Drug: ⁶⁸Ga-FC516 |
| ⁶⁸Ga-FC516 and ⁶⁸Ga-labeled prostate cancer-targeting tracer PET/CT | Experimental | Drug: ⁶⁸Ga-FC516 and ⁶⁸Ga-labeled prostate cancer-targeting tracer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ⁶⁸Ga-FC516Healthy subjects will receive ⁶⁸Ga-FC516 injection followed by PET/CT scans at multiple timepoints post-administration. | Drug | ⁶⁸Ga-FC516 PET/CT |
| ⁶⁸Ga-FC516 and ⁶⁸Ga-labeled prostate cancer-targeting tracerPatients with prostate cancer will undergo both ⁶⁸Ga-FC516 and ⁶⁸Ga-labeled prostate cancer-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 prostate cancer-targeting tracer PET/CT |
Primary outcome
Frequency of adverse events (AEs) and SAEs
Time frame: Approximately 6 months
Standard uptake value (SUV) of tumors
Time frame: Approximately 6 months
Compare the SUV of tumor between 68Ga-FC516 PET/CT and 68Ga-labeled prostate cancer-targeting tracer PET/CT
Human dosimetry
Time frame: Approximately six months
Radiation dose to individual organs and the equivalent dose for the whole body of each subject.
1 secondary outcome
Tumor detection rate
Time frame: Approximately six months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ⁶⁸Ga-FC516 and ⁶⁸Ga-FC516 and ⁶⁸Ga-labeled prostate cancer-targeting tracer in people with Healthy Adult and Prostate Cancer, run by FindCure Biosciences (ZhongShan) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tingjin Wang (18664044814, wangtingjin@find-cure.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of adverse events (AEs) and SAEs (time frame: Approximately 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.