YN001 in Healthy Subjects and Patients With Coronary Atherosclerosis

Part I- Inclusion Criteria: Fully understand the purposes, features, and methods of the study and the possible adverse reactions, voluntarily participate in the study as a subject, and sign the informed consent form (ICF) before performing any assessment. Chinese healthy male or female subjects between 18 and 55 years (inclusive, at the time of signing the ICF). A Body Mass Index (BMI) of 18~28 kg/m2 (inclusive), with a body weight of at least 50 kg for males and 45 kg for females. Be in good general health at discretion of the investigator. Female subjects must be non-pregnant and non-lactating, and women of childbearing potential (including the male subject's female companion) must agree to use effective method of contraception from the screening period to 3 months after receiving their last dose of the investigational drug. Willing and able to comply with the requirements of protocol. Part I- Exclusion Criteria: Prior treatment with other investigational drug(s) within 3 months or 5 half-lives, whichever is longer, prior to the first dosing. Prior treatment with any prescription drugs, or any type of vaccination within 2 weeks prior to the first dosing. Presenting with history of severe food allergy. Allergy to multiple kinds of drugs or presenting with history of allergic reactions to any components of the study drug. Known any clinically abnormal diseases or factors that, in the opinion of the investigator, makes the subject inappropriate for inclusion in this study. Presence of hypothyroidism. Presenting and/ or relapse history (within the last 3 years) of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated, or not treated) or cardiac dysfunction or myocardial infarction. Known inflammatory bowel disease, ulcers, gastrointestinal or rectal bleeding within 6 months prior to the first dosing. Presenting with history of pancreatic injury or pancreatitis within 6 months prior to the first dosing. Presence of symptoms of urinary obstruction or difficulty in voiding. Presenting and/ or relapse history (within the last 3 years) of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc.). Evidence of major diseases that not recovered within 2 weeks prior to the first dosing, or major surgery is expected during the study. Presenting with history of impaired renal function defined by clinically significantly abnormal creatinine or BUN(Blood Urea Nitrogen) and/ or urea values, or abnormal urinary constituents (e.g., albuminuria). Presence of liver disease or liver injury, defined by abnormal liver function tests. Donation or blood loss is more than 400 mL within 3 months prior to screening. Use more than 10 cigarettes per day or habitual use of nicotine-containing products within 3 months prior to screening. Presenting with history of drug abuse within 12 months prior to screening, or use of any drugs within 3 months prior to screening, or a positive result of drug abuse screen at screening. Consumption of more than 14 standard drinks of alcohol per week within 3 months prior to screening, or consumption of alcohol-containing products 48 hours prior to the first dosing or having positive alcohol breath test at baseline. Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), human immunodeficiency virus (HIV), or treponema pallidum antibody (TP-Ab). Presence of any other diseases or conditions that, in the opinion of the investigator, would make it unsuitable for the subject to participate in this study. Part II- Inclusion Criteria: Fully understand the purposes, features, and methods of the study and the possible adverse reactions, voluntarily participate in the study as a subject, and sign the ICF before performing any assessment. Chinese male or female subjects between 18 and 75 years (inclusive, at the time of signing the ICF). Patients diagnosed with confirmed coronary atherosclerosis and 25-75% stenosis. Vulnerable plaque determined by an optical coherence tomography (OCT) examination. Targeted segment of vessel must be at least 40 mm in length. Female subjects must be non-pregnant and non-lactating, and women of childbearing potential (including the male subject's female companion) must agree to use effective method of contraception from the screening period to 3 months after receiving their last dose of the investigational drug. Willing and able to comply with the requirements of protocol. Part II- Exclusion Criteria: Prior treatment with other investigational drug(s) within 30 days or 5 half-lives, whichever is longer, prior to the first dosing. Prior treatment with any supplements known to alter the study drug's metabolism or other supplements judged by the investigator to influence the study drug within 2 weeks prior to the first dosing. Any type of vaccination prior to the first dosing. Presence of moderate or heavily calcification lesion in target vessel. Known heterozygous or homozygous familial hypercholesterolemia. Relapse and highly symptomatic arrhythmia uncontrolled by drugs within the past 3 months. Presenting with history of any type of stroke. Known inflammatory bowel disease, ulcers, gastrointestinal or rectal bleeding within 6 months prior to the first dosing. Presenting with history of pancreatic injury or pancreatitis within 6 months prior to the first dosing. Evidence of major diseases that not recovered within 2 weeks prior to the first dosing, or major surgery is expected during the study. Presenting with history of malignancy, or cancer within the past 2 years. Presence of any type of autoimmune disease. Allergy to multiple food or drugs or presenting with history of allergic reactions to any components of the study drug. Prior treatment with CABG(coronary artery bypass graft), PCI(Percutaneous coronary intervention), heart transplantation, SAVR(Surgical aortic valve replacement)/TAVR(Transcatheter aortic valve replacement), etc., or CABG, PCI(Percutaneous coronary intervention), heart transplantation, SAVR/TAVR, etc., is planned during the study. Left ventricular ejection fraction (LVEF) <40%. Left main coronary artery stenosis ≥ 50%. Uncontrolled hypertension, defined as systolic blood pressure≥150 mmHg or diastolic blood pressure≥100 mmHg in resting status. Active liver disease or hepatic dysfunction. Presence of renal insufficiency. Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), human immunodeficiency virus (HIV), or treponema pallidum antibody (TP-Ab). Presence of any other diseases or conditions that, in the opinion of the investigator, would make it unsuitable for the subject to participate in this study.