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A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single & Multiple Ascending Dose Study to Access the Tolerability and Pharmacokinetics of HEC110114 Tablets in Healthy Adult Subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 100 mg single dose | Experimental | It includes two groups, one group is pilot study, healthy subjects receive a single dose of 100 mg HEC110114 tablet (N=2) . Another group is formal study, healthy subjects receive a single dose of 100 mg HEC110114 tablet (N=8) or matching placebo (N=2) |
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| 300 mg single dose | Experimental | Healthy subjects, receiving a single dose of 300 mg HEC110114 tablet (N=8) or matching placebo (N=2) |
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| 600 mg single dose | Experimental | Healthy subjects, receiving a single dose of 600 mg HEC110114 tablet (N=8) or matching placebo (N=2) |
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| 800 mg single dose | Experimental | Healthy subjects, receiving a single dose of 800 mg HEC110114 tablet (N=16) or matching placebo (N=2) under fed or fasted conditions, this group is a two-sequence, two-period crossover study |
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| 1000 mg single dose | Experimental | Healthy subjects, receiving a single dose of 1000 mg HEC110114 tablet (N=8) or matching placebo (N=2) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HEC110114 tablet | Drug | administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Percentage of Participants with Adverse Events | From Days 1-12 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum Observed Plasma Concentration | At pre-defined intervals from Days 1-12 |
| Tmax | Time to Maximum Observed Plasma Concentration |
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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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| 1200 mg single dose | Experimental | Healthy subjects, receiving a single dose of 1200 mg HEC110114 tablet (N=8) or matching placebo (N=2) |
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| 1600 mg single dose | Experimental | Healthy subjects, receiving a single dose of 1600 mg HEC110114 tablet (N=8) or matching placebo (N=2) |
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| 600 mg multiple doses | Experimental | Healthy subjects, receiving 600 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days |
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| 800 mg multiple doses | Experimental | Healthy subjects, receiving 800 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days |
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| 1000 mg multiple doses | Experimental | Healthy subjects, receiving 1000 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days |
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| Placebo Oral Tablet | Drug | Placebo will be administered orally at a dose and frequency matched to HEC110114 |
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| At pre-defined intervals from Days 1-12 |
| AUClast | Area Under the Plasma Concentration vs Time Curve to Last Measurable Concentration | At pre-defined intervals from Days 1-12 |
| AUC0-∞ | Area Under the Plasma Concentration vs Time Curve Extrapolated to Infinity | At pre-defined intervals from Days 1-12 |
| T1/2 | Apparent Half-Life | At pre-defined intervals from Days 1-12 |
| CL/F | Clearance (CL/F) of HEC110114 | At pre-defined intervals from Days 1-12 |
| Cmin | Trough Plasma Concentration of HEC110114 | At pre-defined intervals from Days 1-11 for MAD |
| 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 |