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This is a first in human study of single and multiple ascending doses and food effect of ASC42.
This study consists of 8 cohorts and is divided as follows:
Part Ia: Single ascending doses study including cohorts 1 to 5. Part Ib: A cross-over design of cohort 2 to study the food effect on ASC42 PK. Part II: Multiple ascending doses study including cohorts 6 to 8.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Ascending Dose-ASC42 | Experimental | ASC42 tablet，Dose 1，Dose 2，Dose 3，Dose 4，and Dose 5, single dose administration |
|
| Multiple Ascending Dose-ASC42 | Experimental | ASC42 tablet, Dose 1，Dose 2，Dose 3，q.d.×14 days |
|
| Single Ascending Dose-Placebo | Placebo Comparator | Placebo tablet，Dose 1，Dose 2，Dose 3，Dose 4，and Dose 5, single dose administration |
|
| Multiple Ascending Dose-Placebo | Placebo Comparator | Placebo tablet，Dose 1，Dose 2，Dose 3，q.d.×14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASC42 | Drug | Oral tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 21 days | Up to 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| AUC of ASC42 | Evaluate the Area under the plasma concentration versus time curve after single and multiple oral doses of ASC42 administered to healthy volunteers. | On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days. |
| Cmax of ASC42 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON early Phase Services LLC | San Antonio | Texas | 78209 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37919483 | Derived | He H, Wu JJ. Human Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC42, a Novel Farnesoid X Receptor Agonist. Drugs R D. 2023 Dec;23(4):453-464. doi: 10.1007/s40268-023-00444-4. Epub 2023 Nov 2. |
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| Placebo |
| Drug |
Oral tablets |
|
Evaluate the Peak Plasma Concentration after single and multiple oral doses of ASC42 administered to healthy volunteers. |
| On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days. |
| t1/2 of ASC42 | Evaluate the Terminal-Phase Half-Life after single and multiple oral doses of ASC42 administered to healthy volunteers. | On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days. |
| CL/F of ASC42 | Evaluate the Apparent Systemic Clearance after single and multiple oral dose of ASC42 administered to healthy volunteers. | On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days. |
| Vd/F of ASC42 | Evaluate the Apparent Volume of Distribution after single and multiple oral dose of ASC42 administered to healthy volunteers. | On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days. |
| Tmax of ASC42 | Evaluate the Time to reach the maximum plasma concentration after single single and multiple oral doses of ASC42 administered to healthy volunteers. | On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days. |
| C4 | Bile acid precuisor:C4 (7αhydroxy-4-cholesten-3-one) | On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days. |
| FGF19 | Bile acid precursor:FGF19 (Fibroblast growth factor 19) | On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days. |