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Предстои набиране Фаза 2 NCT07303777

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

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Atherosclerosis Cardiovascular Disease ASCVD ASCVD Management

Спонсор: Atom Therapeutics Co., Ltd

Налично на: БГ
Обобщение
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.
Кой може да участва
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.
Места на провеждане 3
Австралия (1)
NovaTrails
Newcastle , New South Wales
Китай (1)
Beijing Friendship Hospital, Capital Medical University
Beijing
САЩ (1)
Cardiovascular Research Foundation of Southern California
Beverly Hills , California
Технически детайли
Статус
Предстои набиране
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
75 Years
Здрави доброволци
Не
Начална дата
01.04.2026
Крайна дата
01.04.2028
Регистрационен номер
NCT07303777
Източник
anzctr
Запитване за медицински туризъм

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