Phase 1 Study of 18FMODAG-009 PET Radiotracer to Assess Its Behavior and Safety in Healthy Adults Aged 18 to 60

What this Trial Is About

Researchers are conducting an open-label, single-center phase 1 study to better understand the characteristics of 18FMODAG-009 in healthy adult volunteers aged 18 to 60 years. The study aims to evaluate the pharmacokinetics, biodistribution, and radiation dosimetry of this PET radiotracer, focusing on safety and tolerability from baseline up to 7 days after injection. Participants will receive a single intravenous dose of 18FMODAG-009 followed by whole-body PET imaging covering the area from the skull vertex to mid-thigh. Imaging sessions may include up to three scans within 6 hours post-injection. Blood and urine samples will be collected to analyze radiometabolites and urinary radioactivity. Safety assessments will be performed on the imaging day and about a week later. During the study, participants will undergo physical exams, vital sign checks, ECGs, laboratory tests, and adverse event monitoring. Researchers will measure safety and tolerability, biodistribution, pharmacokinetics, whole-body excretion, and radiation dose to organs during the 6-hour imaging period. Follow-up contact occurs 7 days post-injection to ensure participant safety. About six healthy volunteers will take part in this research lasting several days.

Evaluation of the Pharmacokinetics, Biodistribution and Radiation Dosimetry of [18F]MODAG-009 Positron Emission Tomography (PET) Radiotracers in Adult Healthy Volunteers