Recombinant Human Thymosin Beta 4 for Injection(NL005) for Acute Myocardial Infarction
8 de maio de 2026 atualizado por: 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
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Estimado)
189
Estágio
- Fase 2
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Yue Liu
- Número de telefone: +86-10-82890893
- E-mail: liuyue@northland-bio.com
Estude backup de contato
- Nome: Yinjian Sun
- Número de telefone: +86-10-82890893
- E-mail: sunyinjian@northland-bio.com
Locais de estudo
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100037
- Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)
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Contato:
- Kefei Dou
- Número de telefone: +86-13801032912
- E-mail: drdoukefei@126.com
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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)
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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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Experimental: 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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Comparador de Placebo: 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.
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Myocardial Infarct Size (absolute) at Day 90
Prazo: 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
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Myocardial Infarct Size (absolute) at Day 6
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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.
Prazo: 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)
Prazo: 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)
Prazo: Baseline and Day 30
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Baseline and Day 30
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Peak Concentration (Cmax)
Prazo: 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)
Prazo: Days 1-7 (post-dose)
|
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)
Prazo: Days 1-7 (post-dose)
|
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)
Prazo: Days 1-7 (post-dose)
|
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)
Prazo: Days 1-7 (post-dose)
|
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)
Prazo: Days 1-7 (post-dose)
|
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)
Prazo: Days 1-7 (post-dose)
|
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)
Prazo: Days 1-7 (post-dose)
|
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)
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Left Ventricular Ejection Fraction (LVEF) at 1 Year
Prazo: 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
Prazo: Day 360 (±14 days)
|
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)
Prazo: First dose through Day 360
|
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.
|
First dose through Day 360
|
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Incidence of New-Onset Major Diseases at 1 Year
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Kefei Dou, Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
18 de maio de 2026
Conclusão Primária (Estimado)
17 de agosto de 2027
Conclusão do estudo (Estimado)
17 de maio de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
30 de abril de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
8 de maio de 2026
Primeira postagem (Real)
14 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
14 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
8 de maio de 2026
Última verificação
1 de abril de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- NL005-AMI-IIc
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Recombinant Human Thymosin Beta 4 Injection (NL005)
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