A Phase 1 interventional study of Flotufolastat F-18 Injection in Prostate Cancer, sponsored by Sinotau Pharmaceutical Group. Recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-02.
Sponsored by Sinotau Pharmaceutical Group · Phase 1, Interventional, and Diagnostic
Flotufolastat F-18 Injection is a positron emission tomography (PET) imaging tracer that targets the extracellular domain of prostate-specific membrane antigen (PSMA). This phase I study investigated the safety, biodistribution, radiation dosimetry and Pharmacokinetics of Flotufolastat F-18 Injection in 6 healthy elderly Chinese volunteers.
Flotufolastat F-18 Injection is a positron emission tomography (PET) imaging tracer that targets the extracellular domain of prostate-specific membrane antigen (PSMA). It is intended for the detection of prostate cancer (PCa) lesions.This Phase I study will be open-labeled, nonrandomized, single center study. Enrolled 6 healthy Chinese volunteers who meet all of the inclusion and none of the exclusion criteria. Subjects will receive 5.47\~6.69mCi of Flotufolastat F-18 Injection via IV injection. Safety and tolerability will be observed. Biodistribution, pharmacokinetics, and dosimetry will be investigated.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 6 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Sinotau Pharmaceutical Group is the lead sponsor of 17 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
With chronic diseases, including but not limited to:
Single dose 5.47\~6.69mCi mCi intravenous injection of Flotufolastat F-18 Injection
Drug: Flotufolastat F-18 Injection
Single dose intravenous injection of Flotufolastat F-18 Injection . Serial whole-body PET scan will be obtain after injection, blood and urine collection after injection for the assessment of pharmacokinetics.
To evaluate the biodistribution of Flotufolastat F-18 Injection after a single bolus intravenous injection in healthy Chinese adults. (%ID)
Radioactive accumulation (%ID) in target organs following administration of Flotufolastat F-18 Injection.
Time frame: Day 1
To evaluate the biodistribution of Flotufolastat F-18 Injection after a single bolus intravenous injection in healthy Chinese adults.
Standardized uptake value (SUV) in target organs following administration of Flotufolastat F-18 Injection.
Time frame: Day 1
To assess the radiation dosimetry of Flotufolastat F-18 Injection
Radiation dose in target organs and whole-body effective dose following administration of Flotufolastat F-18 Injection
Time frame: Day 1
To evaluate the pharmacokinetic of Flotufolastat F-18 Injection
Radioactivity concentration (%ID/g) in whole blood, plasma, and urine samples at various time points post Flotufolastat F-18 Injection, and associated time activity curves.
Time frame: Day 1
Proportions of radioactive parent compound in plasma
To evaluate the pharmacokinetic of Flotufolastat F-18 Injection
Time frame: Day 1
To evaluate the safety profile of Flotufolastat F-18 Injection
Types, severity, incidence, and outcomes of adverse events (AEs) and serious adverse events (SAEs) reported during the study period
Time frame: Day 2
Plan to share: No
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Sinotau Pharmaceutical Group