The purpose of this study is, to assess whether EDP239 can reduce the HCV viral load in HCV gentotype-1 in chronically infected subjects and to further evaluate the safety profile of EDP239.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
28
Investigative Site
Miami, Florida, United States
Investigative Site
San Antonio, Texas, United States
Investigative Site
Murray, Utah, United States
Investigative Site
Frankfurt, Germany
Investigative Site
Change from baseline Hepatitis C viral load at Day 1
Blood will be collected for Hepatitis C viral load at Day 1.
Time frame: baseline, day 1
Number of participants with adverse events as a measure of safety
Laboratory and clinical evaluations will be used as safety events
Time frame: 14 days
Change from baseline in HCV RNA log
A viral load drop in excess of 2.5 will be considered a success.
Time frame: baseline, Day 1
Total concentration in plasma of EDP239 in HCV Gentoype 1 infected subjects
The concentration in plasma parameters of EDP239 will be determined using the actual recorded sampling times and non-compartmental method.
Time frame: baseline, day 1
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Hamburg, Germany