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Recombinant Human Thymosin Beta 4 for Injection(NL005) for Acute Myocardial Infarction

8. května 2026 aktualizováno: 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

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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 studie

Intervenční

Zápis (Odhadovaný)

189

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

  • Čína
    • Beijing Municipality
      • Beijing, Beijing Municipality, Čína, 100037
        • Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Lék: Recombinant Human Thymosin Beta 4 Injection (NL005)
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.
Experimentální: 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.
Lék: Recombinant Human Thymosin Beta 4 Injection (NL005)
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.
Komparátor placeba: 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.
Lék: Placebo
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 je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Myocardial Infarct Size (absolute) at Day 90
Časové okno: 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
Časové okno: 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)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Myocardial Infarct Size (absolute) at Day 6
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: Baseline (pre-dose), Day 2/3/7/30/90
Baseline (pre-dose), Day 2/3/7/30/90
Biomarkers: soluble ST2 (sST2)
Časové okno: 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)
Časové okno: Baseline (pre-dose), Day 2/3/7/30/90
Baseline (pre-dose), Day 2/3/7/30/90
Biomarkers: creatine kinase-MB (CK-MB)
Časové okno: 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)
Časové okno: 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.
Časové okno: Day 90 (±7 days)
Day 90 (±7 days)
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Časové okno: 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)
Časové okno: Baseline and Day 30
Baseline and Day 30
Peak Concentration (Cmax)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Left Ventricular Ejection Fraction (LVEF) at 1 Year
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Beijing Northland Biotech. Co., Ltd.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Kefei Dou, Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

18. května 2026

Primární dokončení (Odhadovaný)

17. srpna 2027

Dokončení studie (Odhadovaný)

17. května 2028

Termíny zápisu do studia

První předloženo

30. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

8. května 2026

První zveřejněno (Aktuální)

14. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

14. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

8. května 2026

Naposledy ověřeno

1. dubna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • NL005-AMI-IIc

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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