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호주 관상동맥경화증 환자의 YN001-004

2026년 9월 21일 업데이트: Beijing Inno Medicine Co., Ltd.

관상동맥경화증 환자를 대상으로 YN001의 유효성과 안전성을 평가하기 위한 호주의 2a상 임상시험

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)

연구 개요

상태

종료됨

정황

개입 / 치료

상세 설명

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 24 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 (12 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).

연구 유형

중재적

등록 (실제)

3

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Tugun, 호주
        • John Flynn Private Hospital
    • Australian Capital Territory
      • Canberra, Australian Capital Territory, 호주
        • Canberra Hospital
    • New South Wales
      • Albury, New South Wales, 호주, 1125
        • Albury Wodonga Private Hospital
    • Queensland
      • Birtinya, Queensland, 호주, 4575
        • Sunshine Coast University Private Hospital
    • Victoria
      • Melbourne, Victoria, 호주, 3025
        • Altona Clinical Research
      • Melbourne, Victoria, 호주, 3199
        • Peninsula Heart Centre

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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. Multi-vessel severe disease.
  6. Recent acute ST-segment elevation myocardial infarction (STEMI) occurred within 2 weeks prior to randomization.
  7. 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.
  8. Prior treatment with CABG, heart transplantation, SAVR/TAVR, etc., or CABG, heart transplantation, SAVR/TAVR, etc., is required or planned during the study.
  9. PCI performed within 4 weeks prior to randomization or PCI is required or planned during study treatment.
  10. New York Heart Association (NYHA) class III or IV, or last known left ventricular ejection fraction (LVEF) <40%.
  11. Recent clinically evident stroke occurred within 6 months prior to randomization (except for TIA).
  12. Presenting with history of myopathy/myalgia, or susceptible to myopathy/rhabdomyolysis.
  13. Known inflammatory bowel disease, ulcers, gastrointestinal or rectal bleeding within 6 months prior to randomization.
  14. Evidence of major diseases that not recovered within 2 weeks prior to randomization, or major surgery is expected during the study.
  15. 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).
  16. Presence of any type of autoimmune disease.
  17. Allergy to multiple food or drugs or known sensitivity to any components to be administered during dosing
  18. Life expectancy is less than 1 year.
  19. Systolic blood pressure of ≥150 mmHg at final screening despite antihypertensive therapy.
  20. Known familial hypercholesterolemia
  21. Triglycerides≥400 mg/dl (4.5 mmol/l) at final screening.
  22. 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.
  23. Presence of renal insufficiency.
  24. Untreated or inadequately treated hypothyroidism defined by thyroid stimulating hormone (TSH) > 1.5 times ULN at final screening.
  25. Poorly controlled (defined by HbA1c > 9%) type 2 diabetes mellitus.
  26. 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).
  27. Current smoker who has smoked an average of≥5 cigarettes (or equivalent) per day over the preceding year.
  28. 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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Dose 1 treatment arm

Dose 1 YN001 will be administrated intravenously weekly.

Dose 1 YN001 will be administered on Day 1 of each week from Week 1 to Week 13, 13 times in total.

Evolocumab 140 mg will be administered subcutaneously every 2 weeks.

다른 이름들:
  • 레파타®
실험적: Dose 2 treatment arm

Dose 2 YN001 will be administrated intravenously weekly.

Evolocumab 140 mg will be administered subcutaneously every 2 weeks.

다른 이름들:
  • 레파타®

Dose 2 YN001 will be administered on Day 1 of each week from Week 1 to Week 13, 13 times in total.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Changes in coronary plaque characteristics (volume and composition)
기간: From baseline to Week 13

Evaluating YN001 on top of evolocumab therapy in changing coronary plaque volume assessed by coronary computed tomography angiography (CCTA).

From baseline to Week 13

2차 결과 측정

결과 측정
측정값 설명
기간
Change in mean of mean carotid IMT
기간: From baseline to Week 13

Evaluating YN001 on top of evolocumab therapy in changing carotid intima-media thickness (IMT) assessed by carotid ultrasound.

From baseline to Week 13
Change in mean of mean carotid IMT
기간: From baseline to Week 5

Evaluating YN001 on top of evolocumab therapy in changing carotid intima-media thickness (IMT) assessed by carotid ultrasound.

From baseline to Week 5
Change in mean of mean carotid IMT
기간: From baseline to Week 9

Evaluating YN001 on top of evolocumab therapy in changing carotid intima-media thickness (IMT) assessed by carotid ultrasound.

From baseline to Week 9
Change in mean peri-coronary Fat attenuation index (FAI)
기간: From baseline to Week 13

Evaluating YN001 on top of evolocumab therapy in changing inflammation using the peri-coronary FAI value measured by quantitative CTA analysis.

From baseline to Week 13
The safety profile of YN001
기간: From baseline to Week 15

Incidence of Adverse events (AEs)/Serious adverse events (SAEs)

From baseline to Week 15
Plasma concentration of total and free drug
기간: From Week 1 to Week 13

Plasma concentration of total and free drug at pre-dose (0 h) and at the end of infusion

From Week 1 to Week 13
Population pharmacokinetics (PK)
기간: From Week 1 to Week 13

Plasma PK parameter (AUC) and patient covariates of interest will be evaluated graphically and in the population PK model.

From Week 1 to Week 13

기타 결과 측정

결과 측정
측정값 설명
기간
Immunogenicity(ADA) analysis
기간: From Week 1 to Week 13

The proportion of patients who develop anti-drug antibodies (ADA) following drug administration.

From Week 1 to Week 13
Immunogenicity (APA)analysis
기간: From screening to Week 13

The proportion of patients with pre-exsiting anti-PEG antibodies (APA), treatment emergent APA or treatment boosted APA following drug administration.

From screening to Week 13
Exploratory dose-response analysis of plaque volume
기간: From Week 1 to Week 13

Exploratory dose-response analysis will be performed by comparing the difference of coronary plaque volume changing between 2 different dose levels

From Week 1 to Week 13
Exploratory dose-response analysis of AEs
기간: From Week 1 to Week 13

Exploratory dose-response analysis will be performed by comparing the difference of incidence of AEs between 2 different dose levels

From Week 1 to Week 13

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 연구 책임자: Teresa Chen, PhD, Beijing Inno Medicine Co., Ltd.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 2월 25일

기본 완료 (실제)

2026년 7월 22일

연구 완료 (실제)

2026년 7월 22일

연구 등록 날짜

최초 제출

2024년 11월 14일

QC 기준을 충족하는 최초 제출

2024년 11월 19일

처음 게시됨 (실제)

2024년 11월 22일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 23일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 21일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • YN001-004

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .