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news.Critical Biologics has announced the successful enrollment of the first four patients in its 'first-in-man' clinical trial for Solinex, an intravenous formulation of recombinant human plasma gelsolin.
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The trial is designed to assess the safety and pharmacokinetics of a single intravenous infusion of recombinant human plasma gelsolin (rhu-pGSN) in critically ill patients with profound hypogelsolinemia in cohorts receiving progressively larger doses of the drug. It is planned to enter a total of 40 patients into the double blind, placebo controlled trial being conducted at a leading medical institution in Hong Kong.
Richard Straube, Critical Biologics’s (CBC) chief medical officer, said: “The results of this trial will provide valuable insights into the mechanism of depletion of the naturally occurring plasma gelsolin. They will also help CBC determine the size and frequency of the Solinex dosing required to increase blood levels of this important protective protein above a critical threshold in hypogelsolinemic patients with a high mortality risk.”