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A Study of ALM-488 to Highlight Nerves in Patients Undergoing Head & Neck Surgery

Surgery Clinical Trial

Official title:
Phase 1/2 Trial of ALM-488 in Patients Undergoing Head & Neck Surgery

Clinical Trial Summary

Phase 1/2 study of ALM-488 to highlight nerves in patients undergoing head & neck surgery.

Clinical Trial Description

This study will evaluate the safety, tolerability, and efficacy of ALM-488 administered as an intravenous (IV) infusion to patients undergoing head & neck surgery. The study will also characterize the pharmacokinetics of ALM-488 in this subject population and determine the dose of ALM-488 needed to generate a fluorescence signal in nerve tissue to enable fluorescence recordings and image analysis with an imaging system. The study will also evaluate the effect of timing of ALM-488 administration, relative to surgery, on fluorescence characteristics. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04420689
Study type Interventional
Source Alume Biosciences, Inc.
Contact
Status Completed
Phase Phase 1/Phase 2
Start date June 18, 2020
Completion date February 15, 2022
View Details
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