The goal of this study is to assess the tolerability, pharmacokinetics and antiviral activity of HEC74647 in HCV treatment naïve subjects with genotypes 1-6.
All subjects will be receive QD doses of HEC74647 or the matching placebo for 3 days to assess the the tolerability, pharmacokinetics and antiviral activity at specified time-points during the study.All subjects also will be monitored for up to 8 days post-dose to determine the persistence of viral mutations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
28
Capsule administered orally once daily
HEC74647PA capsule matching placebo administered orally once daily
The First Hospital of Jilin University
Changchun, Jilin, China
Adverse Events,laboratory abnormalities and other abnormalities
Number of participants with Adverse Events, laboratory abnormalities and other abnormalities following dose administration of HEC74647
Time frame: 8 days
Antiviral Activity
Change from baseline in HCV RNA following dose administration of HEC74647
Time frame: 8 days
Sequence changes in the NS5A coding region
Sequence changes in the NS5A coding region of HCV following multiple dose administration of HEC74647 and for up to 8 days thereafter
Time frame: 8 days
Cmax
Maximum observed plasma concentration of HEC74647
Time frame: 8 days
Tmax
Time of the maximum observed plasma concentration
Time frame: 8 days
AUC
Area under the plasma concentration-time curve (AUC)
Time frame: 8 days
t1/2
Terminal elimination half-life
Time frame: 8 days
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