This is an exploratory clinical study of copper-64 \[Cu-64\]-labeled granzyme B (GzmB)-targeted compounds for PET/CT imaging. The goal is to determine how GzmB-Targeted \[Cu-64\]-labeled compounds are distributed in the body by assessing PET/CT images and blood samples, and to assess the safety profile after a single intravenous dose.
Up to 6 healthy volunteers (3 female, 3 male) will receive one injection of a GzmB-targeted \[Cu-64\]-labeled compound, then undergo multiple whole-body PET/CT scans, blood and urine tests over about 24 hours, and a follow-up phone call around Day 7. Up to 2 GzmB-Targeted \[Cu-64\]-labeled compounds may be assessed (i.e. maximum of 12 healthy volunteers in total in the study).
Researchers will look at the blood activity of GzmB-Targeted \[Cu-64\]-labeled compound and the organ distribution and movement of the product in the body. They will also evaluate any changes in physical examination assessments, vital signs, ECG, and clinical laboratory measurements from pre-administration to post-administration.
Adult male or female participants 18-60 years of age judged to be in good health by the Investigator
No clinically significant laboratory abnormalities; all tests of liver and kidney function within normal limits
Capable of giving signed informed consent, which includes compliance with requirements and restrictions listed in the ICF and this protocol
Female participants of childbearing potential and male participants who are fertile and have female partners of childbearing potential must agree to use adequate birth control throughout the study to the conclusion of follow-up.
Pregnant or breast-feeding female participants (female participants of childbearing potential must have negative pregnancy tests at Screening and pre-dose Day 0)
Inadequate venous access (at least two distinct access sites allowing for separate test agent administration and PK blood sampling are required)
Inability or unwillingness to undergo serial PET/CT imaging
Active infection or malignancy