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.
Have the ability to understand the content of study and voluntarily sign the informed consent form.
Healthy male or female, aged 18-60 (included).
Body mass index (BMI) between 19 and 26 kg/m² (included).
Vital signs, physical examination, 12-lead electrocardiogram (ECG), chest X-ray (posterior-anterior view), and abdominal ultrasound are normal, or any abnormalities that are diagnosed clinically insignificant.
Claustrophobia or inability to tolerate imaging examinations for any other reason.
Have a history of epilepsy or seizures, excluding childhood febrile seizures.
cardiovascular, respiratory, gastrointestinal, urinary, hematological disease, neurological, endocrine, metabolic, or musculoskeletal diseases, or a history thereof.
history of psychiatric disorders or currently significant psychiatric conditions
Single group
Flotufolastat F-18 Injection
DrugSingle 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.
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.
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
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.
Proportions of radioactive parent compound in plasma
To evaluate the pharmacokinetic of Flotufolastat F-18 Injection
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
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