Recombinant Human Thymosin Beta 4 for Injection(NL005) for Acute Myocardial Infarction
2026年5月8日 更新者：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
研究概览
地位
尚未招聘
详细说明
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.
研究类型
介入性
注册 (估计的)
189
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Yue Liu
- 电话号码：+86-10-82890893
- 邮箱：liuyue@northland-bio.com
研究联系人备份
- 姓名：Yinjian Sun
- 电话号码：+86-10-82890893
- 邮箱：sunyinjian@northland-bio.com
学习地点
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Beijing Municipality
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Beijing、Beijing Municipality、中国、100037
- Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)
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接触：
- Kefei Dou
- 电话号码：+86-13801032912
- 邮箱：drdoukefei@126.com
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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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实验性的：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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安慰剂比较：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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Myocardial Infarct Size (absolute) at Day 90
大体时间：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
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Myocardial Infarct Size (absolute) at Day 6
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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.
大体时间：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)
大体时间：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)
大体时间：Baseline and Day 30
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Baseline and Day 30
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Peak Concentration (Cmax)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Left Ventricular Ejection Fraction (LVEF) at 1 Year
大体时间：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
大体时间：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)
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Kefei Dou、Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年5月18日
初级完成 (估计的)
2027年8月17日
研究完成 (估计的)
2028年5月17日
研究注册日期
首次提交
2026年4月30日
首先提交符合 QC 标准的
2026年5月8日
首次发布 (实际的)
2026年5月14日
研究记录更新
最后更新发布 (实际的)
2026年5月14日
上次提交的符合 QC 标准的更新
2026年5月8日
最后验证
2026年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Recombinant Human Thymosin Beta 4 Injection (NL005)的临床试验
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