Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and antiviral activity of single and multiple ascending doses of SH229 in patients with chronic hepatitis C Virus infection.
A total of 30 evaluable patients will be enrolled in this study. The planned dose levels are 400, 600, and 800 mg.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Active Comparator | SH229 (400 mg) or matching placebo, once daily |
|
| Cohort 2 | Active Comparator | SH229 (600 mg) or matching placebo, once daily |
|
| Cohort 3 | Active Comparator | SH229 (800 mg) or matching placebo, once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SH229 | Drug | tablet, oral, 400 mg once daily for 3 days |
| |
| Placebos |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | up to Day 10 | |
| Antiviral effects of SH229, as measured by HCV RNA levels | up to Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to peak plasma concentration(Tmax) | up to Day 10 | |
| Peak plasma concentration(Cmax) | up to Day 10 | |
| Half-life time(t1/2) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yanhua Ding, MD | Phase I Clinical Trial Unit, The First Hospital of Jilin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phase I Clinical Trial Unit, The First Hospital of Jilin University | Changchun | Jilin | 130000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
tablet, oral, once daily for 3 days |
|
| SH229 | Drug | tablet, oral, 600 mg once daily for 3 days |
|
| Placebos | Drug | tablet, oral, once daily for 3 days |
|
| SH229 | Drug | tablet, oral, 800 mg once daily for 3 days |
|
| Placebos | Drug | tablet, oral, once daily for 3 days |
|
| up to Day 10 |
| Area under the plasma concentration versus time curve(AUC) | up to Day 10 |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |