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This is a Phase I Randomized, Double-Blind, Placebo-Controlled, Dose Escalation, Single Center Bridging Study to Evaluate Safety, Tolerability and Pharmacokinetics of ASC42 in Chinese Healthy Subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASC42 Dose A | Experimental | ASC42 tablet Dose A, once daily |
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| Placebo Dose A | Placebo Comparator | Placebo Comparator: Single dose of matched placebo to ASC42 tablet Dose A, once daily |
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| ASC42 Dose B | Experimental | ASC42 tablet Dose B, once daily |
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| Placebo Dose B | Placebo Comparator | Placebo Comparator: Single dose of matched placebo to ASC42 tablet Dose A, once daily |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASC42 | Drug | ASC42 tablet administered orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUC of ASC42 | Evaluate the Area under the plasma concentration versus time curve. | Up to 4 days |
| Cmax of ASC42 | Evaluate the Peak Plasma Concentration. | Up to 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| t1/2 of ASC42 | Evaluate the Terminal-Phase Half-Life. | Up to 4 days |
| CL/F of ASC42 | Evaluate the Apparent Systemic Clearance. | Up to 4 days |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Boai Rehabilitation Hospital | Changsha | Hunan | 410008 | China |
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| Placebo |
| Drug |
Matching placebo administered orally |
|
| Vd/F of ASC42 | Evaluate the Apparent Volume of Distribution. | Up to 4 days |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Occurrence of Serious Adverse Event (SAE), Adverse Event (AE) resulting in treatment discontinuation and/or dose reductions, and AE of special interest, from baseline up to 7 days. | Up to 7 days |