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Recruiting EARLY_Phase 1 NCT07081217
Radiocaine Safety Study In Healthy Human Subjects
Trial Parameters
Condition Healthy Subjects
Sponsor Lutroo Imaging LLC
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 6
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-06-17
Completion 2025-12
Interventions
Intravenous Radiocaine
Brief Summary
This is a Phase 1, single-center, open-label study evaluating the safety, biodistribution, and radiation dosimetry of Radiocaine™, an investigational fluorine-18-labeled PET radiotracer designed to bind voltage-gated sodium channels in pain-related peripheral nerves. The study will enroll healthy adult volunteers and aims to inform future clinical development in pain imaging. Radiocaine™ is being developed as a potential imaging biomarker for the localization and quantification of pain.
Eligibility Criteria
Inclusion Criteria: * Pain-free * Unremarkable baseline health without report of chronic or acute pain Exclusion Criteria: * Physical pain of almost any severity