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A Phase 1a/1b Study of PPI-383 in Healthy Adults and Hepatitis C Patients

Presidio Pharmaceuticals, Inc. · 2013
ClinicalTrials.gov · Datasets · License: Public Domain · 2013
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chronichepatitis-c
PPI-383 is an antiviral agent (an inhibitor of the hepatitis C virus NS5B polymerase) that is being developed as a potential treatment for hepatitis C virus infection. This study is being done to assess the dose-related safety and tolerance of PPI-383 when given to healthy volunteers for up to 5 days (Part I of the study) and to hepatitis C patients for up to 3 days (Part II). In addition, the study will assess how much PPI-383 is absorbed into the bloodstream. In Part II, the dose-related effect of PPI-383 on the amount of hepatitis C virus in patients' bloodstream (serum HCV RNA levels) also will be assessed.
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