Apply to trial NCT07774650

A Study of the Pharmacokinetics, Biodistribution and Dosimetry of Granzyme-B Targeted [Cu-64]-Labeled PET Radiotracers in Adult Healthy Volunteers

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.