YN001-004 in Patients With Coronary Atherosclerosis in Australia

Last updated: March 31, 2025
Sponsor: Beijing Inno Medicine Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Atherosclerosis

Vascular Diseases

Chest Pain

Treatment

Dose 2 YN001

Dose 1 YN001

Evolocumab

Clinical Study ID

NCT06700720
YN001-004
  • Ages 18-75
  • All Genders

Study Summary

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)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Fully understand the purposes, features, and methods of the study, and sign the ICFbefore 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 withdiameter stenosis determined by coronary computed tomography angiography (CTA).

  4. 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.

  5. Willing and able to comply with the requirements of protocol to the best of thepatient's and investigator's knowledge.

Exclusion

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 contrastreactions).

  5. Severe coronary calcification.

  6. Multi-vessel severe disease.

  7. Recent acute ST-segment elevation myocardial infarction (STEMI) occurred within 2weeks prior to randomization.

  8. 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.

  9. Prior treatment with CABG, heart transplantation, SAVR/TAVR, etc., or CABG, hearttransplantation, SAVR/TAVR, etc., is required or planned during the study.

  10. PCI performed within 4 weeks prior to randomization or PCI is required or plannedduring study treatment.

  11. New York Heart Association (NYHA) class III or IV, or last known left ventricularejection 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 antihypertensivetherapy.

  16. Active liver disease or hepatic dysfunction defined by any of ALT, AST, or totalbilirubin > 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 againsthepatitis C virus (anti-HCV) or human immunodeficiency virus (anti-HIV), or positivetreponema 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 toparticipate in this study.

Study Design

Total Participants: 12
Treatment Group(s): 3
Primary Treatment: Dose 2 YN001
Phase: 2
Study Start date:
April 01, 2025
Estimated Completion Date:
September 30, 2025

Study Description

This is a multicenter, randomized, open label, parallel-group, proof of concept study. It is designed to determine if the study drug, called YN001, administered in addition to evolocumab can effectively reduce the total amount of plaque formed in the coronary artery as measured by CCTA from baseline to week 13.

A total of 12 patients with coronary atherosclerosis are expected to be enrolled and will be randomly assigned in a 1:1 ratio to 1 of 2 YN001 treatment arms (6 patients per arm) with 2 different dose levels for 12 weeks.

The study will be comprised of a maximum 41-day screening period (Day -42-Day -2), a baseline period (Day-1), a treatment and observation period (W1D1- W13D7), and a safety follow-up period (14 days post last dose).

Connect with a study center

  • Canberra Hospital

    Canberra, Australian Capital Territory
    Australia

    Site Not Available

  • Albury Wodonga Private Hospital

    Albury, New South Wales 1125
    Australia

    Site Not Available

  • Core Research Group Pty Ltd

    Milton, Queesland
    Australia

    Active - Recruiting

  • Altona Clinical Research

    Melbourne, Victoria 3025
    Australia

    Site Not Available

  • Peninsula Heart Centre

    Melbourne, Victoria 3199
    Australia

    Active - Recruiting

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