NCT07081217

Radiocaine Safety Study In Healthy Human Subjects

[18F]Radiocaine: Radiation and Radiochemical Safety

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Lutroo Imaging LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

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 to voltage-gated sodium channels expressed in peripheral nerves. The study will enroll six healthy adult volunteers, each of whom will receive a single intravenous dose of Radiocaine™. Serial PET/MR imaging will be performed over several hours post-injection to assess the distribution of the radiotracer in various tissues and organs. Blood and urine samples will be collected at predefined timepoints to support pharmacokinetic and dosimetry modeling. Safety assessments-including vital signs, laboratory tests, and monitoring for adverse events-will be conducted throughout the study. The primary objectives are to: * Evaluate the safety and tolerability of a single dose of Radiocaine™ in healthy individuals; * Characterize the biodistribution of Radiocaine™ in key organs and tissues; * Estimate radiation exposure (dosimetry) to inform future clinical use. These data will guide dosing, image acquisition timing, and safety thresholds for upcoming studies in patients with chronic or neuropathic pain. The results will also support the further development of Radiocaine™ as a potential molecular imaging biomarker for the localization and quantification of pain in human subjects. This study is intended for early-stage characterization of Radiocaine™ in preparation for future clinical studies involving patients.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Intravenous Radiocaine	Intravenous injection of Radiocaine

Timeline

• Start date: 2025-06-17
• Primary completion: 2025-12-01
• Completion: 2026-04-01
• First posted: 2025-07-23
• Last updated: 2025-07-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study