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This is a multicenter, randomized, double-blind, placebo parallel controlled study to evaluate the preliminary efficacy, safety, and PopPK profile of ABP-745 in patients with ASCVD. Efficacy of ABP-745 in reducing atherosclerotic plaque compared with placebo will be evaluated in participants with ASCVD. The primary efficacy measurement will be assessed at 52W of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo group | Placebo Comparator | Existing lipid-lowering maintenance medications unchanged. |
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| ABP-745 Dose A | Experimental | Existing lipid-lowering maintenance medications unchanged. |
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| ABP-745 Dose B | Experimental | Existing lipid-lowering maintenance medications unchanged. |
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| ABP-745 Dose C | Experimental | Existing lipid-lowering maintenance medications unchanged. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABP-745 Dose A | Drug | ABP-745 Dose A - tablets (PO), low dose , QD |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from the baseline in percent atheroma volume (PAV) | 52 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change from the baseline in percent atheroma volume (PAV) | 24 weeks after treatment | |
| Incidence of treatment-emergent adverse events (Safety and Tolerability) TEAEs and SAEs, and clinically significant changes in physical examination, vital signs, safety laboratory tests, and 12-lead ECG. |
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Inclusion Criteria:
Unless otherwise specified, subjects must meet all of the following criteria at screening:
Exclusion Criteria:
Unless otherwise specified, subjects are excluded from the study if any of the following criteria is met:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiang Shi | Contact | 86+ 19117302212 | qiang.shi@atombp.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular Research Foundation of Southern California | Not yet recruiting | Beverly Hills | California | 90210 | United States |
There is no such demand at present.
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| Placebo |
| Drug |
ABP-745 placebo - tablets (PO), non-active,QD |
|
| ABP-745 Dose B | Drug | ABP-745 Dose B - tablets (PO), Midum dose, QD |
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| ABP-745 Dose C | Drug | ABP-745 Dose C - tablets (PO), High dose, QD |
|
| up to 14 days post the last dose of study drug |
| Cardiovascular Institute of San Diego INC | Not yet recruiting | San Diego | California | 91911 | United States |
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| The Lundquist Institute | Not yet recruiting | Torrance | California | 90502 | United States |
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| Washington University School of Medicine, St.louis | Not yet recruiting | St Louis | Missouri | 63130 | United States |
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| NovaTrails | Not yet recruiting | Newcastle | New South Wales | 2290 | Australia |
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| University of the Sunshine Coast Clinical Trials Unit - Morayfield | Not yet recruiting | Morayfield | Queensland | 4506 | Australia |
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| Core Research Group Pty Ltd | Not yet recruiting | Brisbane | Australia |
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| UniSC Clinical Trials (Brisbane) | Not yet recruiting | Brisbane | Australia |
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| Cognivus | Not yet recruiting | Wahroonga | Australia |
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| Beijing Friendship Hospital, Capital Medical University | Not yet recruiting | Beijing | China |
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| Peking Union Medical College Hospital | Not yet recruiting | Beijing | China |
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| Peking University First Hospital | Not yet recruiting | Beijing | China |
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| Xuanwu Hospital Capital Medical University | Not yet recruiting | Beijing | China |
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| Dalian Second Hospital | Not yet recruiting | Dalian | China |
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| Guangdong Province Hospital | Not yet recruiting | Guangzhou | China |
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| Sir Run Run Shaw Hospital of Zhejiang University School of Medicine | Not yet recruiting | Hangzhou | China |
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| The First Affiliated Hospital of Zhejiang University school of medicine | Not yet recruiting | Hangzhou | China |
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| Zhejiang Provincial People's Hospital | Not yet recruiting | Hangzhou | China |
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| Jinan Central Hospital | Not yet recruiting | Jinan | China |
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| Jiangsu Province Hospital | Not yet recruiting | Nanjing | China |
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| Nanjing Drum Tower Hospital | Not yet recruiting | Nanjing | China |
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| Huashan Hospital Fudan University | Not yet recruiting | Shanghai | China |
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| Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Not yet recruiting | Shanghai | China |
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| Shanghai General Hospital | Not yet recruiting | Shanghai | China |
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| The Zhongshan Hospital Affiliated to Fudan University | Recruiting | Shanghai | China |
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| The First Affiliated Hospital of Soochow University | Not yet recruiting | Suzhou | China |
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| Tianjin General Hospital | Not yet recruiting | Tianjin | China |
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| Renmin Hospital of Wuhan University | Not yet recruiting | Wuhan | China |
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| Wuxi People's Hospital | Not yet recruiting | Wuxi | China |
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| Shaanxi Provincial People's Hospital | Not yet recruiting | Xi'an | China |
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| The First Affiliated Hospital of Xian Jiaotong University | Not yet recruiting | Xi'an | China |
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| The Second Affiliated Hospital of Xi'an Jiaotong University | Not yet recruiting | Xi'an | China |
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| The Affiliated Hospital of Xuzhou Medical College | Not yet recruiting | Xuzhou | China |
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