Recombinant Human Thymosin Beta 4 for Injection(NL005) for Acute Myocardial Infarction
2026년 5월 8일 업데이트: Beijing Northland Biotech. Co., Ltd.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase IIc Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Recombinant Human Thymosin Beta 4 Injection (NL005) in Patients With Acute Myocardial Infarction
The goal of this phase IIc clinical trial is to learn if recombinant human thymosin beta 4 injection (NL005) works to treat heart damage in people who have had a serious type of heart attack called ST-segment elevation myocardial infarction (STEMI) and have been treated with emergency percutaneous coronary intervention (PCI, a procedure to open the blocked artery). It will also learn about the safety of NL005. The main questions it aims to answer are:
- Does NL005 lower the size of permanent heart muscle damage measured by cardiac magnetic resonance (CMR) scan 90 days after treatment?
- What medical problems do participants have when taking NL005?
Researchers will compare two different doses of NL005 to a placebo (a look-alike substance that contains no drug) to see if NL005 works better to reduce heart damage caused by the heart attack.
Participants will:
- Receive NL005 or placebo through a vein within 4 hours after the PCI procedure, then once a day for 7 days
- Stay in the hospital for the first week for monitoring, blood draws, and electrocardiograms (heart tracings)
- Have a CMR scan on Day 6 and Day 90 to measure the size of the heart injury
- Return to the hospital for checkups on Day 30 and Day 90
- Be contacted by the study team (by phone or online) 3 times during the first year and come back to the hospital on Day 360 to check long-term recovery
연구 개요
상태
아직 모집하지 않음
상세 설명
This multicenter, randomized, double-blind, placebo-controlled, parallel-group phase IIc study evaluates the efficacy, safety, and pharmacokinetics of recombinant human thymosin beta 4 injection (NL005) in patients with acute STEMI undergoing primary PCI. Approximately 189 participants are randomized 1:1:1 to NL005 10 µg/kg, NL005 20 µg/kg, or matching placebo.
Eligible participants have first anterior STEMI from left anterior descending artery occlusion. Full eligibility details are provided in the corresponding module.
The study includes a screening period, a 7-day inpatient treatment phase, follow-up visits at Day 30 and Day 90, and an extended follow-up period through Day 360.
연구 유형
중재적
등록 (추정된)
189
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Yue Liu
- 전화번호: +86-10-82890893
- 이메일: liuyue@northland-bio.com
연구 연락처 백업
- 이름: Yinjian Sun
- 전화번호: +86-10-82890893
- 이메일: sunyinjian@northland-bio.com
연구 장소
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Beijing Municipality
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Beijing, Beijing Municipality, 중국, 100037
- Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)
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연락하다:
- Kefei Dou
- 전화번호: +86-13801032912
- 이메일: drdoukefei@126.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
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아니
설명
Inclusion Criteria:
- Willing and able to provide written informed consent (by the participant or legally authorized representative)
- Aged 18 to 75 years old, any sex
- Diagnosis of ST-segment elevation myocardial infarction (STEMI) with electrocardiogram (ECG) meeting protocol-specified ST-elevation criteria, and scheduled to undergo primary percutaneous coronary intervention (PCI)
- OR, regardless of ECG criteria, the participant has a completely or nearly completely blocked (TIMI flow grade 0 or 1) proximal or mid left anterior descending (LAD) coronary artery as the single culprit vessel
- The blocked LAD artery has no visible collateral blood supply from other coronary arteries (Rentrop grade 0)
- Total myocardial ischemic time (time from chest pain onset to guidewire passage during PCI) meets one of the following: 1. More than 2 hours and less than 6 hours of ischemic time, with either post-PCI LAD TIMI flow grade of 2 or less, or left ventricular ejection fraction (LVEF) of 50% or lower measured by cardiac ultrasound during PCI hospitalization; 2. Between 6 and 24 hours of ischemic time (inclusive)
- Males and females of childbearing potential must agree to use adequate contraception (such as hormonal or barrier methods, or abstinence) throughout the study
Exclusion Criteria:
- Prior history of acute myocardial infarction, chronic total coronary occlusion, coronary thrombolysis, PCI, or coronary artery bypass graft surgery
- Diagnosis of severe acute heart failure (Killip class III or higher) or chronic heart failure (NYHA functional class III or higher)
- Severe, uncontrolled arrhythmia that cannot be corrected
- Presence of aortic dissection
- Severe liver or kidney dysfunction
- History of stroke within the past 6 months
- Current or past diagnosis of any malignancy
- Blood pressure that remains at or above 180 mmHg systolic and/or 110 mmHg diastolic despite adequate antihypertensive treatment
- History of clinically significant allergic reaction, especially known allergy to protein or biologic drugs
- Participation in another clinical study within 3 months before screening
- Unable to undergo cardiac magnetic resonance (CMR) imaging (e.g., due to implanted metal devices, severe claustrophobia, or other contraindications)
- Any other condition that the investigator believes makes participation unsuitable (for example, the need for urgent or planned revascularization of non-LAD coronary arteries within 3 months)
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: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: NL005 10 µg/kg Group
Participants receive recombinant human thymosin beta 4 injection (NL005) at a dose of 10 µg/kg administered as a slow intravenous bolus over approximately 3 minutes.
The first dose is given within 4 hours after guidewire passage during primary PCI, followed by once-daily dosing on Days 2 through 7, for a total of 7 doses.
Each dose is formulated in a total volume of 5 mL.
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NL005 is a sterile solution of recombinant human thymosin beta 4 formulated for intravenous injection.
It is supplied as a 1.5 mg (1 mL) vial and stored at 2-8°C.
For each dose, the appropriate volume is drawn to achieve 10 µg/kg or 20 µg/kg, and the total volume is adjusted to 5 mL with compatible diluent before administration.
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실험적: NL005 20 µg/kg Group
Participants receive recombinant human thymosin beta 4 injection (NL005) at a dose of 20 µg/kg administered as a slow intravenous bolus over approximately 3 minutes.
The first dose is given within 4 hours after guidewire passage during primary PCI, followed by once-daily dosing on Days 2 through 7, for a total of 7 doses.
Each dose is formulated in a total volume of 5 mL.
|
NL005 is a sterile solution of recombinant human thymosin beta 4 formulated for intravenous injection.
It is supplied as a 1.5 mg (1 mL) vial and stored at 2-8°C.
For each dose, the appropriate volume is drawn to achieve 10 µg/kg or 20 µg/kg, and the total volume is adjusted to 5 mL with compatible diluent before administration.
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위약 비교기: Placebo Group
Participants receive matching placebo (a sterile solution with identical appearance to NL005 but containing no active ingredient) administered as a slow intravenous bolus over approximately 3 minutes.
The first dose is given within 4 hours after guidewire passage during primary PCI, followed by once-daily dosing on Days 2 through 7, for a total of 7 doses.
Each dose is formulated in a total volume of 5 mL.
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The placebo is a sterile solution identical in appearance to NL005 and contains no active ingredient.
It is supplied as a 1 mL vial and stored at 2-8°C.
Each dose is formulated in a total volume of 5 mL and administered intravenously.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Myocardial Infarct Size (absolute) at Day 90
기간: Day 90 (±7 days)
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Myocardial infarct size measured by late gadolinium enhancement cardiac magnetic resonance (LGE-CMR), expressed in absolute (grams).
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Day 90 (±7 days)
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Myocardial Infarct Size (relative) at Day 90
기간: Day 90 (±7 days)
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Myocardial infarct size measured by LGE-CMR, expressed in relative (percentage of LV mass), calculated as (infarct mass / total LV mass) × 100%.
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Day 90 (±7 days)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Myocardial Infarct Size (absolute) at Day 6
기간: Day 6 (±1 day)
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Myocardial infarct size measured by LGE-CMR, expressed in absolute (grams).
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Day 6 (±1 day)
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Myocardial Infarct Size (relative) at Day 6
기간: Day 6 (±1 day)
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Myocardial infarct size measured by LGE-CMR, expressed in relative (percentage of LV mass), calculated as (infarct mass / total LV mass) × 100%.
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Day 6 (±1 day)
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Microvascular Obstruction (MVO)(absolute)
기간: Day 6 (±1 day), Day 90 (±7 days)
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MVO measured by LGE-CMR, expressed in absolute (grams).
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Day 6 (±1 day), Day 90 (±7 days)
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MVO (relative)
기간: Day 6 (±1 day), Day 90 (±7 days)
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MVO measured by LGE-CMR, expressed in relative (percentage of LV mass), calculated as (MVO mass / total LV mass) × 100%.
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Day 6 (±1 day), Day 90 (±7 days)
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Left Ventricular Ejection Fraction (LVEF)
기간: Day 6 (±1 day), Day 90 (±7 days)
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LVEF measured by CMR.
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Day 6 (±1 day), Day 90 (±7 days)
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Left Ventricular End Systolic Volume index (LVESVi)
기간: Day 6 (±1 day), Day 90 (±7 days)
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LVESVi=left ventricular end systolic volume (LVESV)/body surface area (BSA, m²), LVESV measured by CMR.
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Day 6 (±1 day), Day 90 (±7 days)
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Left Ventricular End Diastolic Volume index (LVEDVi)
기간: Day 6 (±1 day), Day 90 (±7 days)
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LVEDVi=left ventricular end diastolic volume (LVDSV)/body surface area (BSA, m²), LVEDV measured by LGE-CMR.
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Day 6 (±1 day), Day 90 (±7 days)
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LVEF at Day 90 Change from Day 6
기간: Day 6 (±1 day), Day 90 (±7 days)
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Change from Day 6 to Day 90.
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Day 6 (±1 day), Day 90 (±7 days)
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LVEDVi at Day 90 Change from Day 6
기간: Day 6 (±1 day), Day 90 (±7 days)
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Change from Day 6 to Day 90.
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Day 6 (±1 day), Day 90 (±7 days)
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LVESVi at Day 90 Change from Day 6
기간: Day 6 (±1 day), Day 90 (±7 days)
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Change from Day 6 to Day 90.
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Day 6 (±1 day), Day 90 (±7 days)
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Biomarkers: N-terminal pro-B-type natriuretic peptide (NT-proBNP)
기간: Baseline (pre-dose), Day 2/3/7/30/90
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Baseline (pre-dose), Day 2/3/7/30/90
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Biomarkers: soluble ST2 (sST2)
기간: Baseline (pre-dose), Day 2/3/7/30/90
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Baseline (pre-dose), Day 2/3/7/30/90
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Biomarkers: high-sensitivity cardiac troponin I (hs-cTnI)
기간: Baseline (pre-dose), Day 2/3/7/30/90
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Baseline (pre-dose), Day 2/3/7/30/90
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Biomarkers: creatine kinase-MB (CK-MB)
기간: Baseline (pre-dose), Day 2/3/7/30/90
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Baseline (pre-dose), Day 2/3/7/30/90
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Biomarkers: high-sensitivity C-reactive protein (hs-CRP)
기간: Baseline (pre-dose), Day 2/3/7/30/90
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Baseline (pre-dose), Day 2/3/7/30/90
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Proportion of participants with persistent MVO at Day 90.
기간: Day 90 (±7 days)
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Day 90 (±7 days)
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Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
기간: First dose through Day 360
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An adverse event (AE) is any untoward medical occurrence, regardless of causal relationship to study drug.
A treatment-emergent adverse event (TEAE) is defined as an event that starts or worsens in severity on or after the first dose.
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First dose through Day 360
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Incidence of Anti-Drug Antibodies (ADA)
기간: Baseline and Day 30
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Baseline and Day 30
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Peak Concentration (Cmax)
기간: Days 1-7 (post-dose)
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Each participant contributes a total of 4 venous blood samples during Days 1-7, with one sample drawn at each of the following post-dose time points: 3-5 minutes, 15±3 minutes, 3±15 hours, and 6±15 hours.
Plasma concentrations of NL005 are measured using a validated assay.
The parameter is estimated by population PK modeling, combining data from this study with data from a prior Phase I study.
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Days 1-7 (post-dose)
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Time to Maximum Concentration (Tmax)
기간: Days 1-7 (post-dose)
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Each participant contributes a total of 4 venous blood samples during Days 1-7, with one sample drawn at each of the following post-dose time points: 3-5 minutes, 15±3 minutes, 3±15 hours, and 6±15 hours.
Plasma concentrations of NL005 are measured using a validated assay.
The parameter is estimated by population PK modeling, combining data from this study with data from a prior Phase I study.
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Days 1-7 (post-dose)
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Area under the plasma concentration-time curve from time zero to the last quantifiable rime point after administration (AUC0-t)
기간: Days 1-7 (post-dose)
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Each participant contributes a total of 4 venous blood samples during Days 1-7, with one sample drawn at each of the following post-dose time points: 3-5 minutes, 15±3 minutes, 3±15 hours, and 6±15 hours.
Plasma concentrations of NL005 are measured using a validated assay.
The parameter is estimated by population PK modeling, combining data from this study with data from a prior Phase I study.
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Days 1-7 (post-dose)
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Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf)
기간: Days 1-7 (post-dose)
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Each participant contributes a total of 4 venous blood samples during Days 1-7, with one sample drawn at each of the following post-dose time points: 3-5 minutes, 15±3 minutes, 3±15 hours, and 6±15 hours.
Plasma concentrations of NL005 are measured using a validated assay.
The parameter is estimated by population PK modeling, combining data from this study with data from a prior Phase I study.
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Days 1-7 (post-dose)
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Elimination half-life (t1/2)
기간: Days 1-7 (post-dose)
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Each participant contributes a total of 4 venous blood samples during Days 1-7, with one sample drawn at each of the following post-dose time points: 3-5 minutes, 15±3 minutes, 3±15 hours, and 6±15 hours.
Plasma concentrations of NL005 are measured using a validated assay.
The parameter is estimated by population PK modeling, combining data from this study with data from a prior Phase I study.
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Days 1-7 (post-dose)
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Elimination rate constant (λz)
기간: Days 1-7 (post-dose)
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Each participant contributes a total of 4 venous blood samples during Days 1-7, with one sample drawn at each of the following post-dose time points: 3-5 minutes, 15±3 minutes, 3±15 hours, and 6±15 hours.
Plasma concentrations of NL005 are measured using a validated assay.
The parameter is estimated by population PK modeling, combining data from this study with data from a prior Phase I study.
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Days 1-7 (post-dose)
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Clearance (CL)
기간: Days 1-7 (post-dose)
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Each participant contributes a total of 4 venous blood samples during Days 1-7, with one sample drawn at each of the following post-dose time points: 3-5 minutes, 15±3 minutes, 3±15 hours, and 6±15 hours.
Plasma concentrations of NL005 are measured using a validated assay.
The parameter is estimated by population PK modeling, combining data from this study with data from a prior Phase I study.
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Days 1-7 (post-dose)
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Volume of distribution (Vz)
기간: Days 1-7 (post-dose)
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Each participant contributes a total of 4 venous blood samples during Days 1-7, with one sample drawn at each of the following post-dose time points: 3-5 minutes, 15±3 minutes, 3±15 hours, and 6±15 hours.
Plasma concentrations of NL005 are measured using a validated assay.
The parameter is estimated by population PK modeling, combining data from this study with data from a prior Phase I study.
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Days 1-7 (post-dose)
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Left Ventricular Ejection Fraction (LVEF) at 1 Year
기간: Day 360 (±14 days)
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LVEF measured by cardiac ultrasound at the Day 360 visit, expressed as a percentage.
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Day 360 (±14 days)
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Quality of Life Assessed by the Minnesota Living with Heart Failure Questionnaire (MLHFQ) at 1 Year
기간: Day 360 (±14 days)
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MLHFQ score at Day 360.
The MLHFQ contains 21 items, each scored 0 (no impact) to 5 (very severe impact).
The total score ranges from 0 to 105, where higher scores represent worse health-related quality of life.
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Day 360 (±14 days)
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Incidence of Major Adverse Cardiovascular Event (MACE)
기간: First dose through Day 360
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MACE is a composite endpoint defined as the first occurrence of any of the following: acute myocardial infarction, hospitalization for heart failure, or cardiovascular death.
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First dose through Day 360
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Incidence of New-Onset Major Diseases at 1 Year
기간: First dose through Day 360
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New-Onset Major Diseases including clinical events such as heart failure, recurrent myocardial infarction, malignancy, or death from any cause.
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First dose through Day 360
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Kefei Dou, Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)
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 (추정된)
2026년 5월 18일
기본 완료 (추정된)
2027년 8월 17일
연구 완료 (추정된)
2028년 5월 17일
연구 등록 날짜
최초 제출
2026년 4월 30일
QC 기준을 충족하는 최초 제출
2026년 5월 8일
처음 게시됨 (실제)
2026년 5월 14일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 8일
마지막으로 확인됨
2026년 4월 1일
추가 정보
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. .