Radiocaine Safety Study In Healthy Human Subjects
Purpose
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.
Condition
- Healthy Subjects
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Pain-free - Unremarkable baseline health without report of chronic or acute pain
Exclusion Criteria
- Physical pain of almost any severity
Study Design
- Phase
- Early Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Healthy subjects |
|
Recruiting Locations
Stanford, California 94305
More Details
- NCT ID
- NCT07081217
- Status
- Recruiting
- Sponsor
- Lutroo Imaging LLC
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.