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The Safety, Tolerability, Pharmacokinetic, Pharmacodynamics and Food Effect Study of HEC96719 in Healthy Subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose of HEC96719 (Part 1,Fed/Fasting) | Experimental | Following an overnight fast of at least 10 hours, a single dose of HEC96719 will be administered on 2 separate occasions (fasting and after meal) in a randomized crossover fashion with different food restrictions. |
|
| Mulltiple doses HEC96719( Part 2, Cohort 1) | Experimental | Healthy subjects receive multiple doses of HEC96719 or matching placebo |
|
| Mulltiple doses HEC96719( Part 2, Cohort 2) | Experimental | Healthy subjects receive multiple doses of HEC96719 or matching placebo |
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| Mulltiple doses HEC96719( Part 2, Cohort 3) | Experimental | Healthy subjects receive multiple doses of HEC96719 or matching placebo |
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| Mulltiple doses HEC96719( Part 2, Cohort 4) | Experimental | Healthy subjects receive multiple doses of HEC96719 or matching placebo |
|
| Mulltiple doses HEC96719( Part 2, Cohort 5) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HEC96719 | Drug | Part 2:Mulltiple doses up to 10 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of HEC96719 by Assessment of the Number of Adverse Events | To investigate the safety and tolerability of HEC96719 by assessment of AEs (non-serious and serious) following administration of oral solution in MAD | up to 17 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum Plasma Concentration(Cmax)of HEC96719 | up to 96 hours |
| AUC | Area Under the Curve(AUC) of HEC96719 | up to 96 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Shanghai xuhui district central hospital | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| Experimental |
Healthy subjects receive multiple doses of HEC96719 or matching placebo |
|
| Tmax | Maximum Peak Time(Tmax) of HEC96719 | up to 96 hours |
| T1/2 | Maximum Peak Time(Tmax) of HEC96719 | up to 96 hours |