A Phase 1, Open-label Study to Assess Safety, Biodistribution, and Internal Radiation Dosimetry of rhPSMA-7.3 (18F) Injection in Healthy Volunteers, and to Assess Safety and Investigate the Imaging Characteristics in Subjects With Prostate Cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
24
Radioligand for PET CT scanning
Clinical Research Services Turku - CRST Oy
Turku, Finland
Number of Participants With Treatment-emergent Adverse Events as Classified by MedDRA
Safety will be assessed from data on the occurrence of one or more treatment-emergent Adverse Events from the time of intravenous administration of 18F-rhPSMA-7.3 throughout the study period, and changes in serum biochemistry, hematology, coagulation, urinalysis, vital signs, Electrocardiogram (ECG), injection site status, and physical examination findings.
Time frame: 1 month
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