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This randomized, double-blind, placebo-controlled single ascending dose (SAD)/ multiple ascending dose (MAD) study is designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ASC30 injection
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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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| SAD Cohort 6 | Experimental | SAD Dose 6 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASC30 Injection, for subcutaneous use or placebo | Drug | Drug: ASC30 injection, for subcutaneous use Drug: Placebo injection, for subcutaneous use |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of AEs, SAEs (Safety and tolerability) of ASC30 | A summary of AEs, SAEs and other non-serious adverse events | Up to Day169 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of ASC30 | PK parameters of ASC30 | Up to Day169 |
| Change From Baseline in Body Weight | Change From Baseline in Body Weight | Up to Day169 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ascletis clinical site | San Antonio | Texas | 78209 | United States |
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| SAD Cohort 7 | Experimental | SAD Dose 7 |
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| SAD Cohort 8 | Experimental | SAD Dose 8 |
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| MAD Cohort 1 | Experimental | MAD Dose 1 |
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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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