YN001-004 in Patients With Coronary Atherosclerosis in Australia

Recruiting now · Phase 2

Conditions studied: Coronary Artery Disease, Coronary Atherosclerotic Disease

In brief

This study is to evaluate the efficacy and safety of intravenously administered YN001 in patients with coronary atherosclerosis in Australia. This study will be conducted in eligible participants with a diagnosis of coronary atherosclerosis, and at least 1 coronary artery is blocked determined by coronary computed tomography angiography (CCTA)

Key facts

Study ID

NCT06700720

Run by

Beijing Inno Medicine Co., Ltd.

People needed

24

Starts

2026-02-01

Expected to finish

2026-06-01

Last updated by the study team

2026-02-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Fully understand the purposes, features, and methods of the study, and sign the ICF before performing any assessment.
• Male or female Australia patients between 18 and 75 years.
• Patients diagnosed with coronary atherosclerosis, and at least 1 vessel with diameter stenosis determined by coronary computed tomography angiography (CTA).
• Female patients must be non-pregnant and non-lactating, and females of childbearing potential (including a female partner of a male patient) must agree to use 1 effective contraception method from the screening period to 3 months after receiving their last dose of the study drug. In addition, male patients must be willing to refrain from sperm donation during this time.
• Willing and able to comply with the requirements of protocol to the best of the patient's and investigator's knowledge.

You may not qualify if…

• Prior treatment with other investigational drug(s) within 30 days or 5 half-lives, whichever is longer, prior to randomization.
• Previously received YN001.
• Any type of vaccination within 4 weeks prior to randomization.
• Contraindication for coronary CTA (e.g., known history of anaphylactic contrast reactions).
• Multi-vessel severe disease.
• Recent acute ST-segment elevation myocardial infarction (STEMI) occurred within 2 weeks prior to randomization.
• Relapse and highly symptomatic arrhythmia uncontrolled by drugs within the past 3 months, such as ventricular tachycardia, atrial fibrillation with rapid ventricular rate and paroxysmal supraventricular tachycardia.
• Prior treatment with CABG, heart transplantation, SAVR/TAVR, etc., or CABG, heart transplantation, SAVR/TAVR, etc., is required or planned during the study.
• PCI performed within 4 weeks prior to randomization or PCI is required or planned during study treatment.
• New York Heart Association (NYHA) class III or IV, or last known left ventricular ejection fraction (LVEF) <40%.
• Recent clinically evident stroke occurred within 6 months prior to randomization (except for TIA).
• Presenting with history of myopathy/myalgia, or susceptible to myopathy/rhabdomyolysis.
• Known inflammatory bowel disease, ulcers, gastrointestinal or rectal bleeding within 6 months prior to randomization.
• Evidence of major diseases that not recovered within 2 weeks prior to randomization, or major surgery is expected during the study.
• Presenting with history of malignancy (except in patients who have been disease-free >5 years; or whose only malignancy has been basal or squamous cell skin carcinoma).
• Presence of any type of autoimmune disease.
• Allergy to multiple food or drugs or known sensitivity to any components to be administered during dosing
• Life expectancy is less than 1 year.
• Systolic blood pressure of ≥150 mmHg at final screening despite antihypertensive therapy.
• Known familial hypercholesterolemia
• Triglycerides≥400 mg/dl (4.5 mmol/l) at final screening.
• Active liver disease or hepatic dysfunction defined by any of ALT, AST, or total bilirubin > 2 times upper limit of normal (ULN) at final screening.
• Presence of renal insufficiency.
• Untreated or inadequately treated hypothyroidism defined by thyroid stimulating hormone (TSH) > 1.5 times ULN at final screening.
• Poorly controlled (defined by HbA1c > 9%) type 2 diabetes mellitus.

Where it is running

• Peninsula Heart Centre — Melbourne, Victoria, Australia (enrolling)
• Albury Wodonga Private Hospital — Albury, New South Wales, Australia (enrolling)
• Sunshine Coast University Private Hospital — Birtinya, Queensland, Australia (enrolling)
• Canberra Hospital — Canberra, Australian Capital Territory, Australia (enrolling)
• Altona Clinical Research — Melbourne, Victoria, Australia (enrolling)
• Core Research Group Pty Ltd — Milton, Queesland, Australia
• John Flynn Private Hospital — Tugun, Australia

Full record on ClinicalTrials.gov

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