ASCVD, ASCVD Management, Atherosclerosis Cardiovascular Disease
Conditions
Keywords
ASCVD, ABP-745
Brief 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.
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
Sponsors
Atom Therapeutics Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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, 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from the baseline in percent atheroma volume (PAV) | 52 weeks after treatment |
Secondary
| Measure | 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. | up to 14 days post the last dose of study drug |
Countries
Australia, China, United States
Contacts
CONTACTQiang Shi
Outcome results
None listed