The overall study design includes two parts, Part A and Part B. Part A evaluated ANA773 following oral administration to healthy volunteers. A total of 40 evaluable healthy volunteers were enrolled in Part A of the study. Part B evaluated ANA773 following oral administration to patients with chronic HCV infection. A total of 34 evaluable patients were enrolled in Part B of this study in 2 study centers.
Study Design: Part A evaluated ANA773 following oral administration to healthy volunteers. A total of 40 evaluable healthy volunteers were enrolled in Part A of the study. Part B evaluated ANA773 following oral administration to patients with chronic HCV infection. A total of 34 evaluable patients were enrolled in Part B of this study in 2 study centers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
75
Academisch Medisch Centrum (AMC)
Amsterdam, Netherlands
PRA Clinical Research Unit
Groningen, Netherlands
Erasmus MC (EMC)
Rotterdam, Netherlands
Safety and Pharmacokinetic Analysis in both Healthy Subjects and Chronic HCV Patients
Evaluate the Safety and Pharmacokinetic Analysis in both Healthy Subjects and Chronic HCV Patients
Time frame: Up to 41 Days
Immunological effects in both Healthy Subjects and Chronic HCV Patients
Evaluate the immunological effects and antiviral activity as assessed by changes in HCV RNA levels.
Time frame: Up to 41 days
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