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This is a phase 1, open-label study in healthy adults. This study is aimed at evaluating the safety, tolerability, and pharmacokinetics of ASC43F, a fixed-dose combination (FDC) and single dose tablet containing ASC41, a THR β agonist and ASC42, an FXR agonist in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | ASC43F for all subjects under the fasted state. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASC43F | Drug | One dose of oral ASC43F FDC tablet containing ASC41 5mg and ASC42 15mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of ASC43F evaluated by incidence of treatment emergent adverse events (TEAEs). | Baseline to day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the pharmacokinetics as assessed by Cmax (Max Concentration) of ASC43F tablet following a single fixed oral dose in healthy subjects | Baseline to day 4 | |
| To evaluate the pharmacokinetics as assessed by Area Under the Curve (AUC) of ASC43F tablet following a single fixed oral dose in healthy subjects |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 8307 Gault Lane | San Antonio | Texas | 78209 | United States |
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| Baseline to day 4 |
| To evaluate the pharmacokinetics as assessed by Tmax (Time to Max Concentration) of ASC43F tablet following a single fixed oral dose in healthy subjects | Baseline to day 4 |