Recombinant Human Thymosin Beta 4 for Injection(NL005) for Acute Myocardial Infarction
8 maja 2026 zaktualizowane przez: 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
Przegląd badań
Status
Jeszcze nie rekrutacja
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Szacowany)
189
Faza
- Faza 2
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Yue Liu
- Numer telefonu: +86-10-82890893
- E-mail: liuyue@northland-bio.com
Kopia zapasowa kontaktu do badania
- Nazwa: Yinjian Sun
- Numer telefonu: +86-10-82890893
- E-mail: sunyinjian@northland-bio.com
Lokalizacje studiów
-
-
Beijing Municipality
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Beijing, Beijing Municipality, Chiny, 100037
- Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)
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Kontakt:
- Kefei Dou
- Numer telefonu: +86-13801032912
- E-mail: drdoukefei@126.com
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-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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)
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Poczwórny
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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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Eksperymentalny: 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.
|
|
Komparator 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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Myocardial Infarct Size (absolute) at Day 90
Ramy czasowe: 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
Ramy czasowe: 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)
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Myocardial Infarct Size (absolute) at Day 6
Ramy czasowe: Day 6 (±1 day)
|
Myocardial infarct size measured by LGE-CMR, expressed in absolute (grams).
|
Day 6 (±1 day)
|
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Myocardial Infarct Size (relative) at Day 6
Ramy czasowe: 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%.
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Day 6 (±1 day)
|
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Microvascular Obstruction (MVO)(absolute)
Ramy czasowe: Day 6 (±1 day), Day 90 (±7 days)
|
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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: Day 6 (±1 day), Day 90 (±7 days)
|
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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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.
Ramy czasowe: 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)
Ramy czasowe: 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.
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First dose through Day 360
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Incidence of Anti-Drug Antibodies (ADA)
Ramy czasowe: Baseline and Day 30
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Baseline and Day 30
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Peak Concentration (Cmax)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
|
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Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
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Volume of distribution (Vz)
Ramy czasowe: 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)
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Left Ventricular Ejection Fraction (LVEF) at 1 Year
Ramy czasowe: Day 360 (±14 days)
|
LVEF measured by cardiac ultrasound at the Day 360 visit, expressed as a percentage.
|
Day 360 (±14 days)
|
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Quality of Life Assessed by the Minnesota Living with Heart Failure Questionnaire (MLHFQ) at 1 Year
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Śledczy
- Główny śledczy: Kefei Dou, Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
18 maja 2026
Zakończenie podstawowe (Szacowany)
17 sierpnia 2027
Ukończenie studiów (Szacowany)
17 maja 2028
Daty rejestracji na studia
Pierwszy przesłany
30 kwietnia 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
8 maja 2026
Pierwszy wysłany (Rzeczywisty)
14 maja 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
14 maja 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
8 maja 2026
Ostatnia weryfikacja
1 kwietnia 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- NL005-AMI-IIc
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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