Results of the first-in-human clinical trial for MB-102, a novel fluorescent tracer agent for real-time measurement of glomerular filtration rate

Richard B. Dorshow; Martin P Debreczeny; Thomas C. Dowling

doi:10.1117/12.2078346

12 March 2015 Results of the first-in-human clinical trial for MB-102, a novel fluorescent tracer agent for real-time measurement of glomerular filtration rate

Richard B. Dorshow, Martin P Debreczeny, Thomas C. Dowling

Author Affiliations +

Proceedings Volume 9339, Reporters, Markers, Dyes, Nanoparticles, and Molecular Probes for Biomedical Applications VII; 933906 (2015) https://doi.org/10.1117/12.2078346
Event: SPIE BiOS, 2015, San Francisco, California, United States

Abstract

The fluorescent tracer agent 2,5-bis[N-(1-carboxy-2-hydroxy)]carbamoyl-3,6-diaminopyrazine, designated MB-102, has been developed with properties and attributes necessary for use as a direct measure of glomerular filtration rate (GFR). Comparison to known standard exogenous GFR agents in animal models has demonstrated an excellent correlation. A clinical trial to demonstrate this same correlation in humans is in progress. This clinical trial is the first in a series of trials necessary to obtain regulatory clearance from the FDA. We report herein the comparison of plasma pharmacokinetics between MB-102 and the known standard exogenous GFR agent Iohexol in healthy subjects with normal renal function. Post simultaneous administration of both agents, blood samples over a period of 12 hours were collected from each subject to assess pharmacokinetic parameters including GFR. Urine samples were collected over this same period to assess percent injected dose recovered in the urine. Results indicate MB-102 is a GFR agent in humans from the comparison to the standard agent.

Citation Download Citation

Richard B. Dorshow, Martin P Debreczeny, and Thomas C. Dowling "Results of the first-in-human clinical trial for MB-102, a novel fluorescent tracer agent for real-time measurement of glomerular filtration rate", Proc. SPIE 9339, Reporters, Markers, Dyes, Nanoparticles, and Molecular Probes for Biomedical Applications VII, 933906 (12 March 2015); https://doi.org/10.1117/12.2078346

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