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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, efficacy, food effect of ASC30 Tablets or ASC30 Tablets A1 in participants with obesity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAD Cohort 1 | Experimental | SAD dose 1 |
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| SAD Cohort 2 | Experimental | SAD dose 2 |
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| SAD Cohort 3 | Experimental | SAD dose 3 |
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| SAD Cohort 4 | Experimental | SAD dose 4 |
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| SAD Cohort 5 | Experimental | SAD dose 5 |
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| MAD Cohort 1 | Experimental | MAD dose 1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASC30 | Drug | Tablet, QD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of AEs, SAEs (Safety and Tolerability) of ASC30 (SAD) | A summary of AEs, SAEs and other non-serious adverse events | Up to Day 8 |
| Incidence of AEs, SAEs (Safety and Tolerability) of ASC30 (MAD) | A summary of AEs, SAEs and other non-serious adverse events | Up to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of ASC30 (SAD) | PK parameters of ASC30 | Up to Day 8 |
| Cmax of ASC30 (MAD) | PK parameters of ASC30 | Up to Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ascletis clinical site | Salt Lake City | Utah | 84124 | United States |
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| MAD Cohort 2 |
| Experimental |
MAD dose 2 |
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| MAD Cohort 3 | Experimental | MAD dose 3 |
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| Placebo | Other | Tablets, QD |
|
| Change From Baseline in Body Weight (MAD) | Change From Baseline in Body Weight | Up to Day 28 |