Recombinant Human Thymosin Beta 4 for Injection(NL005) for Acute Myocardial Infarction
8 мая 2026 г. обновлено: 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
Обзор исследования
Статус
Еще не набирают
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Оцененный)
189
Фаза
- Фаза 2
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Yue Liu
- Номер телефона: +86-10-82890893
- Электронная почта: liuyue@northland-bio.com
Учебное резервное копирование контактов
- Имя: Yinjian Sun
- Номер телефона: +86-10-82890893
- Электронная почта: sunyinjian@northland-bio.com
Места учебы
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Китай, 100037
- Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)
-
Контакт:
- Kefei Dou
- Номер телефона: +86-13801032912
- Электронная почта: drdoukefei@126.com
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
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)
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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.
|
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.
|
|
Экспериментальный: 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.
|
|
Плацебо Компаратор: 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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Myocardial Infarct Size (absolute) at Day 90
Временное ограничение: Day 90 (±7 days)
|
Myocardial infarct size measured by late gadolinium enhancement cardiac magnetic resonance (LGE-CMR), expressed in absolute (grams).
|
Day 90 (±7 days)
|
|
Myocardial Infarct Size (relative) at Day 90
Временное ограничение: Day 90 (±7 days)
|
Myocardial infarct size measured by LGE-CMR, expressed in relative (percentage of LV mass), calculated as (infarct mass / total LV mass) × 100%.
|
Day 90 (±7 days)
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Myocardial Infarct Size (absolute) at Day 6
Временное ограничение: Day 6 (±1 day)
|
Myocardial infarct size measured by LGE-CMR, expressed in absolute (grams).
|
Day 6 (±1 day)
|
|
Myocardial Infarct Size (relative) at Day 6
Временное ограничение: Day 6 (±1 day)
|
Myocardial infarct size measured by LGE-CMR, expressed in relative (percentage of LV mass), calculated as (infarct mass / total LV mass) × 100%.
|
Day 6 (±1 day)
|
|
Microvascular Obstruction (MVO)(absolute)
Временное ограничение: Day 6 (±1 day), Day 90 (±7 days)
|
MVO measured by LGE-CMR, expressed in absolute (grams).
|
Day 6 (±1 day), Day 90 (±7 days)
|
|
MVO (relative)
Временное ограничение: Day 6 (±1 day), Day 90 (±7 days)
|
MVO measured by LGE-CMR, expressed in relative (percentage of LV mass), calculated as (MVO mass / total LV mass) × 100%.
|
Day 6 (±1 day), Day 90 (±7 days)
|
|
Left Ventricular Ejection Fraction (LVEF)
Временное ограничение: Day 6 (±1 day), Day 90 (±7 days)
|
LVEF measured by CMR.
|
Day 6 (±1 day), Day 90 (±7 days)
|
|
Left Ventricular End Systolic Volume index (LVESVi)
Временное ограничение: Day 6 (±1 day), Day 90 (±7 days)
|
LVESVi=left ventricular end systolic volume (LVESV)/body surface area (BSA, m²), LVESV measured by CMR.
|
Day 6 (±1 day), Day 90 (±7 days)
|
|
Left Ventricular End Diastolic Volume index (LVEDVi)
Временное ограничение: Day 6 (±1 day), Day 90 (±7 days)
|
LVEDVi=left ventricular end diastolic volume (LVDSV)/body surface area (BSA, m²), LVEDV measured by LGE-CMR.
|
Day 6 (±1 day), Day 90 (±7 days)
|
|
LVEF at Day 90 Change from Day 6
Временное ограничение: Day 6 (±1 day), Day 90 (±7 days)
|
Change from Day 6 to Day 90.
|
Day 6 (±1 day), Day 90 (±7 days)
|
|
LVEDVi at Day 90 Change from Day 6
Временное ограничение: Day 6 (±1 day), Day 90 (±7 days)
|
Change from Day 6 to Day 90.
|
Day 6 (±1 day), Day 90 (±7 days)
|
|
LVESVi at Day 90 Change from Day 6
Временное ограничение: Day 6 (±1 day), Day 90 (±7 days)
|
Change from Day 6 to Day 90.
|
Day 6 (±1 day), Day 90 (±7 days)
|
|
Biomarkers: N-terminal pro-B-type natriuretic peptide (NT-proBNP)
Временное ограничение: Baseline (pre-dose), Day 2/3/7/30/90
|
Baseline (pre-dose), Day 2/3/7/30/90
|
|
|
Biomarkers: soluble ST2 (sST2)
Временное ограничение: Baseline (pre-dose), Day 2/3/7/30/90
|
Baseline (pre-dose), Day 2/3/7/30/90
|
|
|
Biomarkers: high-sensitivity cardiac troponin I (hs-cTnI)
Временное ограничение: Baseline (pre-dose), Day 2/3/7/30/90
|
Baseline (pre-dose), Day 2/3/7/30/90
|
|
|
Biomarkers: creatine kinase-MB (CK-MB)
Временное ограничение: Baseline (pre-dose), Day 2/3/7/30/90
|
Baseline (pre-dose), Day 2/3/7/30/90
|
|
|
Biomarkers: high-sensitivity C-reactive protein (hs-CRP)
Временное ограничение: Baseline (pre-dose), Day 2/3/7/30/90
|
Baseline (pre-dose), Day 2/3/7/30/90
|
|
|
Proportion of participants with persistent MVO at Day 90.
Временное ограничение: Day 90 (±7 days)
|
Day 90 (±7 days)
|
|
|
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Временное ограничение: First dose through Day 360
|
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.
|
First dose through Day 360
|
|
Incidence of Anti-Drug Antibodies (ADA)
Временное ограничение: Baseline and Day 30
|
Baseline and Day 30
|
|
|
Peak Concentration (Cmax)
Временное ограничение: 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.
|
Days 1-7 (post-dose)
|
|
Time to Maximum Concentration (Tmax)
Временное ограничение: 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.
|
Days 1-7 (post-dose)
|
|
Area under the plasma concentration-time curve from time zero to the last quantifiable rime point after administration (AUC0-t)
Временное ограничение: 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.
|
Days 1-7 (post-dose)
|
|
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf)
Временное ограничение: 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.
|
Days 1-7 (post-dose)
|
|
Elimination half-life (t1/2)
Временное ограничение: 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.
|
Days 1-7 (post-dose)
|
|
Elimination rate constant (λz)
Временное ограничение: 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.
|
Days 1-7 (post-dose)
|
|
Clearance (CL)
Временное ограничение: 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.
|
Days 1-7 (post-dose)
|
|
Volume of distribution (Vz)
Временное ограничение: 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.
|
Days 1-7 (post-dose)
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Left Ventricular Ejection Fraction (LVEF) at 1 Year
Временное ограничение: Day 360 (±14 days)
|
LVEF measured by cardiac ultrasound at the Day 360 visit, expressed as a percentage.
|
Day 360 (±14 days)
|
|
Quality of Life Assessed by the Minnesota Living with Heart Failure Questionnaire (MLHFQ) at 1 Year
Временное ограничение: 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.
|
Day 360 (±14 days)
|
|
Incidence of Major Adverse Cardiovascular Event (MACE)
Временное ограничение: 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
|
|
Incidence of New-Onset Major Diseases at 1 Year
Временное ограничение: First dose through Day 360
|
New-Onset Major Diseases including clinical events such as heart failure, recurrent myocardial infarction, malignancy, or death from any cause.
|
First dose through Day 360
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Главный следователь: Kefei Dou, Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
18 мая 2026 г.
Первичное завершение (Оцененный)
17 августа 2027 г.
Завершение исследования (Оцененный)
17 мая 2028 г.
Даты регистрации исследования
Первый отправленный
30 апреля 2026 г.
Впервые представлено, что соответствует критериям контроля качества
8 мая 2026 г.
Первый опубликованный (Действительный)
14 мая 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
14 мая 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
8 мая 2026 г.
Последняя проверка
1 апреля 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- NL005-AMI-IIc
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .