YN001-004 in Patients With Coronary Atherosclerosis in Australia

Prior treatment

• 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.
• Recent acute ST-segment elevation myocardial infarction (STEMI) occurred within 2 weeks prior to randomization.
• 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.
• Recent clinically evident stroke occurred within 6 months prior to randomization (except for TIA).
• 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.
• Systolic blood pressure of ≥150 mmHg at final screening despite antihypertensive therapy.

Other illness

• Contraindication for coronary CTA (e.g., known history of anaphylactic contrast reactions).
• Multi-vessel severe disease.
• 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.
• Presenting with history of myopathy/myalgia, or susceptible to myopathy/rhabdomyolysis.
• Presence of any type of autoimmune disease.
• Allergy to multiple food or drugs or known sensitivity to any components to be administered during dosing
• Presence of renal insufficiency.
• A positive hepatitis B surface antigen (HBsAg), or positive antibody against hepatitis C virus (anti-HCV) or human immunodeficiency virus (anti-HIV), or positive treponema pallidum antibody (TP-Ab).
• Presence of any other diseases or conditions (apart from those outlined above) that, in the opinion of the investigator, would make it unsuitable for the patient to participate in this study.

Lab values

• New York Heart Association (NYHA) class III or IV, or last known left ventricular ejection fraction (LVEF) <40%.
• 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.
• 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.

Age

• 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).

Other

• Life expectancy is less than 1 year.
• Known familial hypercholesterolemia
• Current smoker who has smoked an average of≥5 cigarettes (or equivalent) per day over the preceding year.

• 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.