Recombinant Human Thymosin Beta 4 for Injection(NL005) for Acute Myocardial Infarction
perjantai 8. toukokuuta 2026 päivittänyt: 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
Tutkimuksen yleiskatsaus
Tila
Ei vielä rekrytointia
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Interventio
Ilmoittautuminen (Arvioitu)
189
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskeluyhteys
- Nimi: Yue Liu
- Puhelinnumero: +86-10-82890893
- Sähköposti: liuyue@northland-bio.com
Tutki yhteystietojen varmuuskopiointi
- Nimi: Yinjian Sun
- Puhelinnumero: +86-10-82890893
- Sähköposti: sunyinjian@northland-bio.com
Opiskelupaikat
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Beijing Municipality
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Beijing, Beijing Municipality, Kiina, 100037
- Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)
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Ottaa yhteyttä:
- Kefei Dou
- Puhelinnumero: +86-13801032912
- Sähköposti: drdoukefei@126.com
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Ei
Kuvaus
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)
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Nelinkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: 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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Kokeellinen: 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.
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Placebo Comparator: 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.
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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.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Myocardial Infarct Size (absolute) at Day 90
Aikaikkuna: 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
Aikaikkuna: 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)
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Myocardial Infarct Size (absolute) at Day 6
Aikaikkuna: Day 6 (±1 day)
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Myocardial infarct size measured by LGE-CMR, expressed in absolute (grams).
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Day 6 (±1 day)
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Myocardial Infarct Size (relative) at Day 6
Aikaikkuna: Day 6 (±1 day)
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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 6 (±1 day)
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Microvascular Obstruction (MVO)(absolute)
Aikaikkuna: Day 6 (±1 day), Day 90 (±7 days)
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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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: Day 6 (±1 day), Day 90 (±7 days)
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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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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.
Aikaikkuna: 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)
Aikaikkuna: First dose through Day 360
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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)
Aikaikkuna: Baseline and Day 30
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Baseline and Day 30
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Peak Concentration (Cmax)
Aikaikkuna: 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)
Aikaikkuna: 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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Area under the plasma concentration-time curve from time zero to the last quantifiable rime point after administration (AUC0-t)
Aikaikkuna: 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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Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf)
Aikaikkuna: 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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Elimination half-life (t1/2)
Aikaikkuna: 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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Elimination rate constant (λz)
Aikaikkuna: 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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Clearance (CL)
Aikaikkuna: 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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Volume of distribution (Vz)
Aikaikkuna: 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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Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Left Ventricular Ejection Fraction (LVEF) at 1 Year
Aikaikkuna: Day 360 (±14 days)
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LVEF measured by cardiac ultrasound at the Day 360 visit, expressed as a percentage.
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Day 360 (±14 days)
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Quality of Life Assessed by the Minnesota Living with Heart Failure Questionnaire (MLHFQ) at 1 Year
Aikaikkuna: Day 360 (±14 days)
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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.
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Day 360 (±14 days)
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Incidence of Major Adverse Cardiovascular Event (MACE)
Aikaikkuna: First dose through Day 360
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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.
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First dose through Day 360
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Incidence of New-Onset Major Diseases at 1 Year
Aikaikkuna: First dose through Day 360
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New-Onset Major Diseases including clinical events such as heart failure, recurrent myocardial infarction, malignancy, or death from any cause.
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First dose through Day 360
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Tutkijat
- Päätutkija: Kefei Dou, Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
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Torstai 30. huhtikuuta 2026
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Perjantai 8. toukokuuta 2026
Ensimmäinen Lähetetty (Todellinen)
Torstai 14. toukokuuta 2026
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
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Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
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Viimeksi vahvistettu
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Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- NL005-AMI-IIc
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Kliiniset tutkimukset Akuutti sydäninfarkti (AMI)
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TherOxLopetettuAnterior Acute Myocardial Infarction (AMI)Yhdysvallat