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

8. mai 2026 oppdatert av: 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

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

189

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100037
        • Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: 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.
Eksperimentell: 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.
Legemiddel: 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.
Placebo komparator: 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.
Legemiddel: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Myocardial Infarct Size (absolute) at Day 90
Tidsramme: 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
Tidsramme: 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)

Sekundære resultatmål

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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Left Ventricular Ejection Fraction (LVEF) at 1 Year
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Beijing Northland Biotech. Co., Ltd.

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

18. mai 2026

Primær fullføring (Antatt)

17. august 2027

Studiet fullført (Antatt)

17. mai 2028

Datoer for studieregistrering

Først innsendt

30. april 2026

Først innsendt som oppfylte QC-kriteriene

8. mai 2026

Først lagt ut (Faktiske)

14. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. mai 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NL005-AMI-IIc

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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