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This is a phase I, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, food effect of ASC50 tablets in healthy adult participants and adult participants with mild to moderate plaque psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAD Cohort 1 | Experimental | Participants will receive a single ASC50 (Dose 1) administration or matching placebo |
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| SAD Cohort 2 | Experimental | Participants will receive a single ASC50 (Dose 2) administration or matching placebo |
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| SAD Cohort 3 | Experimental | Participants will receive a single ASC50 (Dose 3) administration or matching placebo |
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| SAD Cohort 4 | Experimental | Participants will receive a single ASC50 (Dose 4) administration or matching placebo |
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| SAD Cohort 5 | Experimental | Participants will receive a single ASC50 (Dose 5) administration or matching placebo |
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| SAD Cohort 6 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASC50 tablets or matching placebo | Drug | Drug: ASC50 administered orally Drug: Placebo administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs) | Up to Day 7 |
| Adverse Events | Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs) | Up to Day 43 |
| Measure | Description | Time Frame |
|---|---|---|
| AUC | Evaluate the Area under the plasma concentration versus time curve of ASC50 | Up to Day 7 |
| AUC | Evaluate the Area under the plasma concentration versus time curve of ASC50 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vanessa Wang, MD | Contact | +86 18986192094 | global.clinical@ascletis.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ascletis Clinical Site | Recruiting | Miami | Florida | 33144 | United States |
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Participants will receive a single ASC50 (Dose 6) administration or matching placebo |
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| MAD Cohort 1 | Experimental | Participants will receive ASC50 (Dose 1) or matching placebo for 28 days, QD |
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| MAD Cohort 2 | Experimental | Participants will receive ASC50 (Dose 2) or matching placebo for 28 days, QD |
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| MAD Cohort 3 | Experimental | Participants will receive ASC50 (Dose 3) or matching placebo for 28 days, QD |
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| Up to Day 34 |
| Cmax | Evaluate the Peak Plasma Concentration of ASC50 | Up to Day 7 |
| Cmax | Evaluate the Peak Plasma Concentration of ASC50 | Up to Day 34 |
| T1/2 | Evaluate the Terminal-Phase Half-Life of ASC50 | Up to Day 7 |
| T1/2 | Evaluate the Terminal-Phase Half-Life of ASC50 | Up to Day 34 |
| Tmax | Evaluate the time to reach the maximum concentration of ASC50 | Up to Day 7 |
| Tmax | Evaluate the time to reach the maximum concentration of ASC50 | Up to Day 34 |
| IL-17A | Changes in IL-17A after ASC50 administration | Up to Day 7 |
| IL-17A | Changes in IL-17A after ASC50 administration | Up to Day 29 |
| Beta Defensin-2 | Changes in Beta Defensin-2 after ASC50 administration | Up to Day 29 |
| IL-19 | Changes in IL-19 after ASC50 administration | Up to Day 29 |
| Psoriasis Area and Severity Index (PASI) | Changes in Psoriasis Area and Severity Index (PASI) after ASC50 treatment. | Up to Day 43 |
| Target Lesion Severity Score (TLSS) | Changes in Target Lesion Severity Score (TLSS)after ASC50 treatment. | Up to Day 43 |