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news.Callisto Pharmaceuticals has announced that through its wholly-owned subsidiary, Synergy Pharmaceuticals, it has initiated oral dosing of healthy volunteers in a Phase I clinical trial of SP-304.
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The primary objective of the Phase I clinical trial is to assess safety and tolerability of an oral dose of SP-304 in healthy adult volunteers.
SP-304 is an analog of uroguanylin, a natural hormone produced in the gastro-intestinal tract that is a regulator of intestinal function. SP-304 works by activating a unique receptor, the guanylate cyclase C receptor (GC-C) receptor, on intestinal epithelial cells, promoting fluid and ion transport.
Gary Jacob, CEO of Callisto, said: “The start of this first clinical trial with SP-304 marks an important stage in the development of the class of GC-C agonists to treat human gastrointestinal conditions.”