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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
6
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.
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITINGTo 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
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