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

8 maggio 2026 aggiornato da: 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

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

189

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: 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.
Sperimentale: 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.
Droga: 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.
Comparatore 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.
Droga: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Myocardial Infarct Size (absolute) at Day 90
Lasso di tempo: 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
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Myocardial Infarct Size (absolute) at Day 6
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: Baseline (pre-dose), Day 2/3/7/30/90
Baseline (pre-dose), Day 2/3/7/30/90
Biomarkers: soluble ST2 (sST2)
Lasso di tempo: 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)
Lasso di tempo: Baseline (pre-dose), Day 2/3/7/30/90
Baseline (pre-dose), Day 2/3/7/30/90
Biomarkers: creatine kinase-MB (CK-MB)
Lasso di tempo: 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)
Lasso di tempo: 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.
Lasso di tempo: Day 90 (±7 days)
Day 90 (±7 days)
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Lasso di tempo: 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)
Lasso di tempo: Baseline and Day 30
Baseline and Day 30
Peak Concentration (Cmax)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Left Ventricular Ejection Fraction (LVEF) at 1 Year
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Beijing Northland Biotech. Co., Ltd.

Investigatori

  • Investigatore principale: Kefei Dou, Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

18 maggio 2026

Completamento primario (Stimato)

17 agosto 2027

Completamento dello studio (Stimato)

17 maggio 2028

Date di iscrizione allo studio

Primo inviato

30 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

8 maggio 2026

Primo Inserito (Effettivo)

14 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 maggio 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NL005-AMI-IIc

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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