Study of LGW16-03 To Identify Nerves

This is a single-arm, open-label phase I study of LGW16-03, a novel nerve-labeling fluorophore created with the goal of reducing iatrogenic injury to nerves during medical procedures. This study will be conducted in two parts. Part 1-dose escalation- will follow a 3+3 dose-escalation trial design and we will investigate the safety of LGW16-03; pharmacokinetic and fluorescence contrast data will also be collected. Escalation will be stopped if dose-limiting toxicity (DLT) is encountered. Part 2-dose expansion-will continue safety and pharmacokinetic data collection and evaluate further the fluorescence contrast to inform dose. Eligible participants will be limited to healthy patients scheduled for open-field orthopaedic surgical procedures involving exposure of a major compound nerve (i.e., a named nerve with both motor and sensory function). Participants who are determined eligible and who provide informed consent will be administered a single intravenous dose of LGW16-03 on the day of surgery (D0) approximately 60-120 minutes before anticipated induction of anesthesia. Surgical procedures will be conducted per standard of care (SOC) and LGW16-03 will not be used for surgical decision-making. Intraoperative fluorescence imaging (iFI) will begin at the time of first exposure of the target nerve and will be repeated at approximately 30 +/- 15-minute intervals until the target nerve is no longer visible, or the procedure concludes. Imaging will be performed using an FDA-approved fluorescence imaging system (Zeiss Kinevo). At each time point, images of the exposed nerve and adjacent tissues-including muscle, adipose (fat), vasculature, fascia, skin, and/or tendon-will be captured and analyzed for fluorescence signal intensity. These data will be used to calculate nerve-to-background tissue ratios (NBTR) at each time point during the surgery. These data will provide assessment of LGW16-03's ability to provide clinically meaningful intraoperative illumination of the nerve relative to surrounding tissues at the doses being investigated. Additional data will be collected in the form of surveys completed: 1) in real time by the operating surgeon performing trial operations; and 2) surgeons shown images obtained during the surgery who are then asked about the conspicuity of nerve tissue. Up to 24 patients will take part in Part 1, up to 14 patients will take part in Part 2; a maximum of 38 patients will be enrolled in the entire study. Enrollment is expected to take \<18 months. Total time for this protocol is estimated to be 24 months.