Phase 0 Trial of Copper-64 Labeled Granzyme B PET Radiotracers to Study Pharmacokinetics and Safety in Healthy Adults

What This Trial Is About

Researchers are conducting an exploratory Phase 0 clinical trial to study copper-64 Cu-64 labeled granzyme B GzmB-targeted compounds used in PETCT imaging. These compounds are designed to detect immune activation and inflammation by targeting GzmB, an enzyme released by immune cells. The study aims to understand how these compounds spread throughout the body and to assess their safety after a single intravenous dose in healthy adult volunteers. Participants receive a single injection of one of two possible GzmB-targeted Cu-64-labeled PET radiotracers. After administration, they undergo multiple whole-body PETCT scans, along with blood and urine sampling, over a 24-hour period. A follow-up phone call occurs around 7 days after dosing. Up to 12 healthy volunteers will participate, with six receiving each compound. During the trial, participants will have their blood activity levels measured to determine pharmacokinetics, including concentration over time and elimination rate. Researchers will evaluate the distribution of the compound in organs, radiation doses absorbed, and whole-body excretion. Safety assessments include physical exams, vital signs, ECGs, and lab tests conducted from before injection through eight days afterward.

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