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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | up to HEC74647PA capsule 50 mg once daily for 3 days |
|
| Cohort 2 | Experimental | up to HEC74647PA capsule 100 mg once daily for 3 days |
|
| Cohort 3 | Experimental | up to HEC74647PA capsule 200 mg once daily for 3 days |
|
| Cohort 4 | Placebo Comparator | up to placebo once daily for 3 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HEC74647PA capsule | Drug | Capsule administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events,laboratory abnormalities and other abnormalities | Number of participants with Adverse Events, laboratory abnormalities and other abnormalities following dose administration of HEC74647 | 8 days |
| Antiviral Activity | Change from baseline in HCV RNA following dose administration of HEC74647 | 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 | 8 days |
| Cmax | Maximum observed plasma concentration of HEC74647 | 8 days |
| Tmax | Time of the maximum observed plasma concentration | 8 days |
| AUC | Area under the plasma concentration-time curve (AUC) | 8 days |
| t1/2 | Terminal elimination half-life | 8 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yanhua Ding, Doctor | The First Hospital of Jilin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Jilin University | Changchun | Jilin | 130021 | China |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| placebo | Drug | HEC74647PA capsule matching placebo administered orally once daily |
|
| D006525 |
| Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |