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This study is a safety, tolerability, and pharmacokinetics phase Ⅰstudy of HEC96719, in healthy subjects.This study is the healthy adult subjects single ascending-dose research
This study will evaluate the safety and tolerability of escalating single oral doses of HEC96719, and characterize the single-dose pharmacokinetics (PK) of HEC96719. Participants will receive either HEC96719 or HEC96719 placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HEC96719 tablets | Experimental | Including 7 dose groups(0.1、0.2、0.5、1、2、3、4 mg).Each dose group was given only once.After an overnight stay of at least 10h on an empty stomach, 240 mL of water was administered in the morning under the condition of an empty stomach. Water was forbidden for 1h before and 1h after administration, and fasting for 4h after administration. |
|
| placebo tablets | Placebo Comparator | Including 7 dose groups(0.1、0.2、0.5、1、2、3、4 mg).Each dose group was given only once.After an overnight stay of at least 10h on an empty stomach, 240mL of water was administered in the morning under the condition of an empty stomach. Water was forbidden for 1h before and 1h after administration, and fasting for 4h after administration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HEC96719 tablets | Drug | 0.1、0.2、0.5、1、2、3、4 mg HEC96719 tablet in day1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events of the single ascending-dose | To assess the safe and tolerability of the single ascending-dose | From the baseline to day7 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum Plasma Concentration(Cmax)of HEC96719 in single ascending dose | At pre-defined intervals from Days 1-2 |
| AUC | Area Under the Curve(AUC) of HEC96719 in single ascending dose |
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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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| Placebo tablet |
| Drug |
0.1、0.2、0.5、1、2、3、4 mg Placebo tablet in day1 |
|
| At pre-defined intervals from Days 1-2 |
| Tmax | Maximum Peak Time(Tmax) of HEC96719 in single ascending dose | At pre-defined intervals from Days 1-2 |
| T1/2 | Terminal elimination half-life(T1/2) of HEC96719 in single ascending dose | At pre-defined intervals from Days 1-2 |