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