A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy, Safety, and Population Pharmacokinetics (PopPK) Profile of ABP-745 in Patients With Atherosclerosis
Atom Therapeutics Co., Ltd
Summary
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
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
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, su…
Interventions
- DrugABP-745 Dose A
ABP-745 Dose A - tablets (PO), low dose , QD
- DrugPlacebo
ABP-745 placebo - tablets (PO), non-active,QD
- DrugABP-745 Dose B
ABP-745 Dose B - tablets (PO), Midum dose, QD
- DrugABP-745 Dose C
ABP-745 Dose C - tablets (PO), High dose, QD
Locations (33)
- Cardiovascular Research Foundation of Southern CaliforniaBeverly Hills, California
- Cardiovascular Institute of San Diego INCSan Diego, California
- The Lundquist InstituteTorrance, California
- Washington University School of Medicine, St.louisSt Louis, Missouri
- NovaTrailsNewcastle, New South Wales
- University of the Sunshine Coast Clinical Trials Unit - MorayfieldMorayfield, Queensland