Phase
Condition
Coronary Artery Disease
Heart Disease
Myocardial Ischemia
Treatment
Dose 1 YN001
Evolocumab
Dose 2 YN001
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Fully understand the purposes, features, and methods of the study, and sign the ICFbefore performing any assessment.
Male or female Australia patients between 18 and 75 years.
Patients diagnosed with coronary atherosclerosis, and at least 1 vessel withdiameter stenosis determined by coronary computed tomography angiography (CTA).
Female patients must be non-pregnant and non-lactating, and females of childbearingpotential (including a female partner of a male patient) must agree to use 1effective contraception method from the screening period to 3 months after receivingtheir last dose of the study drug. In addition, male patients must be willing torefrain from sperm donation during this time.
Willing and able to comply with the requirements of protocol to the best of thepatient's and investigator's knowledge.
Exclusion
Exclusion Criteria:
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 contrastreactions).
Multi-vessel severe disease.
Recent acute ST-segment elevation myocardial infarction (STEMI) occurred within 2weeks prior to randomization.
Relapse and highly symptomatic arrhythmia uncontrolled by drugs within the past 3months, such as ventricular tachycardia, atrial fibrillation with rapid ventricularrate and paroxysmal supraventricular tachycardia.
Prior treatment with CABG, heart transplantation, SAVR/TAVR, etc., or CABG, hearttransplantation, SAVR/TAVR, etc., is required or planned during the study.
PCI performed within 4 weeks prior to randomization or PCI is required or plannedduring study treatment.
New York Heart Association (NYHA) class III or IV, or last known left ventricularejection 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 tomyopathy/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 beadministered during dosing
Life expectancy is less than 1 year.
Systolic blood pressure of ≥150 mmHg at final screening despite antihypertensivetherapy.
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 totalbilirubin > 2 times upper limit of normal (ULN) at final screening.
Presence of renal insufficiency.
Untreated or inadequately treated hypothyroidism defined by thyroid stimulatinghormone (TSH) > 1.5 times ULN at final screening.
Poorly controlled (defined by HbA1c > 9%) type 2 diabetes mellitus.
A positive hepatitis B surface antigen (HBsAg), or positive antibody againsthepatitis C virus (anti-HCV) or human immunodeficiency virus (anti-HIV), or positivetreponema pallidum antibody (TP-Ab).
Current smoker who has smoked an average of≥5 cigarettes (or equivalent) per dayover the preceding year.
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 toparticipate in this study.
Study Design
Study Description
Connect with a study center
Canberra Hospital
Canberra, Australian Capital Territory
AustraliaSite Not Available
Canberra Hospital
Canberra 2172517, Australian Capital Territory 2177478
AustraliaActive - Recruiting
Albury Wodonga Private Hospital
Albury, New South Wales 1125
AustraliaSite Not Available
Albury Wodonga Private Hospital
Albury 2178174, New South Wales 2155400 1125
AustraliaActive - Recruiting
Sunshine Coast University Private Hospital
Birtinya 8348723, Queensland 2152274 4575
AustraliaActive - Recruiting
Core Research Group Pty Ltd
Milton, Queesland
AustraliaSite Not Available
Core Research Group Pty Ltd
Milton 6943570, Queesland
AustraliaSite Not Available
Altona Clinical Research
Melbourne, Victoria 3025
AustraliaActive - Recruiting
Peninsula Heart Centre
Melbourne, Victoria 3199
AustraliaSite Not Available
Altona Clinical Research
Melbourne 2158177, Victoria 2145234 3025
AustraliaActive - Recruiting
Peninsula Heart Centre
Melbourne 2158177, Victoria 2145234 3199
AustraliaActive - Recruiting

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