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Not yet recruiting Phase 2 NCT07303777

Efficacy, Safety, and PopPK Profile of ABP-745 in Patients With Atherosclerosis

Phase 2 – studying effectiveness and dosage
Conditions: Atherosclerosis Cardiovascular Disease ASCVD ASCVD Management

Sponsor: Atom Therapeutics Co., Ltd

trial.available_in: БГ
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.
Who can participate
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.
Locations 3
Australia (1)
NovaTrails
Newcastle , New South Wales
China (1)
Beijing Friendship Hospital, Capital Medical University
Beijing
United States (1)
Cardiovascular Research Foundation of Southern California
Beverly Hills , California
Technical details
Status
Not yet recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No
Start date
01.04.2026
Completion date
01.04.2028
Registry ID
NCT07303777
Source
anzctr
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