Overview
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.
Eligibility
Inclusion Criteria:
Unless otherwise specified, subjects must meet all of the following criteria at screening:
- Diagnosed with coronary at herosclerosis, and coronary angiography.
- Male or female at 18-75 years of age (inclusive).
- Weight ≥40 kg.
- Currently using any oral lipid-lowering therapy.
- Able to understand and willing to sign an ICF and comply with study requirements.
- A woman or man of childbearing potential agreeing to use medically approved contraceptive methods from the screening until 3 months after the last study dose.
Exclusion Criteria:
Unless otherwise specified, subjects are excluded from the study if any of the following criteria is met:
- History of stroke within the past 6 months.
- Uncontrolled arrhythmia within 3 months prior to screening.
- Evidence of any active or suspected cancer within 3 years prior to the screening.
- Having undergone any major surgery within 3 months prior to the screening or planning to undergo any major surgery during the study.
- Presence or suspicion of ongoing of any serious infection.
- Human immunodeficiency virus (HIV) infection.
