YN001-004 in Patients With Coronary Atherosclerosis in Australia

Launched by BEIJING INNO MEDICINE CO., LTD. · Nov 19, 2024

Keywords

ClinConnect Summary

This clinical trial, called YN001-004, is investigating a treatment called YN001 for patients with coronary atherosclerosis, a condition where the arteries that supply blood to the heart become narrowed due to plaque buildup. The study aims to see how effective and safe this treatment is when given through an intravenous (IV) line. It is currently recruiting participants in Australia who are between 18 and 75 years old and have been diagnosed with this condition, specifically if they have at least one blocked artery confirmed by a special imaging test called coronary computed tomography angiography (CCTA).

To be eligible for this trial, participants must understand the study's goals and agree to take part. Women must not be pregnant or breastfeeding and should use effective contraception during the study. Participants can expect to follow the study's guidelines closely, and they will be monitored for any side effects or benefits from the treatment. However, there are some health conditions and recent medical procedures that may disqualify someone from participating, so it's essential to discuss any medical history with the researchers.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Fully understand the purposes, features, and methods of the study, and sign the ICF before performing any assessment.
• • 2. Male or female Australia patients between 18 and 75 years.
• • 3. Patients diagnosed with coronary atherosclerosis, and at least 1 vessel with diameter stenosis determined by coronary computed tomography angiography (CTA).
• • 4. 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.
• • 5. Willing and able to comply with the requirements of protocol to the best of the patient's and investigator's knowledge.
• Exclusion Criteria:
• • 1. Prior treatment with other investigational drug(s) within 30 days or 5 half-lives, whichever is longer, prior to randomization.
• • 2. Previously received YN001.
• • 3. Any type of vaccination within 4 weeks prior to randomization.
• • 4. Contraindication for coronary CTA (e.g., known history of anaphylactic contrast reactions).
• • 5. Severe coronary calcification.
• • 6. Multi-vessel severe disease.
• • 7. Recent acute ST-segment elevation myocardial infarction (STEMI) occurred within 2 weeks prior to randomization.
• • 8. 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.
• • 9. Prior treatment with CABG, heart transplantation, SAVR/TAVR, etc., or CABG, heart transplantation, SAVR/TAVR, etc., is required or planned during the study.
• • 10. PCI performed within 4 weeks prior to randomization or PCI is required or planned during study treatment.
• • 11. New York Heart Association (NYHA) class III or IV, or last known left ventricular ejection fraction (LVEF) \<40%.
• • 12. Recent clinically evident stroke occurred within 6 months prior to randomization (except for TIA).
• • 13. Evidence of major diseases that not recovered within 2 weeks prior to randomization, or major surgery is expected during the study.
• • 14. 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).
• • 15. Systolic blood pressure of ≥150 mmHg at final screening despite antihypertensive therapy.
• • 16. 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.
• • 17. Presence of renal insufficiency.
• • 18. Poorly controlled (defined by HbA1c \> 9%) type 2 diabetes mellitus.
• • 19. 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).
• • 20. 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.