A Phase 2 interventional study of Recombinant Human Thymosin Beta 4 Injection (NL005) and Placebo in Acute Myocardial Infarction (AMI), Acute Myocardial Infarction of Anterior Wall and Acute Myocardial Infarction With ST Elevation, sponsored by Beijing Northland Biotech. Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by Beijing Northland Biotech. Co., Ltd. · Phase 2, Interventional, and Treatment
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:
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:
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.
34 studies on the registry are indexed under Anterior Wall Myocardial Infarction; 6 are open to participants now.
This study's planned enrollment of 189 is above the median of 120 across 27 interventional studies indexed under Anterior Wall Myocardial Infarction.
Browse Anterior Wall Myocardial Infarction studies →Beijing Northland Biotech. Co., Ltd. is the lead sponsor of 11 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Recombinant Human Thymosin Beta 4 Injection (NL005)
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.
Drug: Recombinant Human Thymosin Beta 4 Injection (NL005)
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.
Drug: Placebo
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.
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.
Myocardial Infarct Size (absolute) at Day 90
Myocardial infarct size measured by late gadolinium enhancement cardiac magnetic resonance (LGE-CMR), expressed in absolute (grams).
Time frame: Day 90 (±7 days)
Myocardial Infarct Size (relative) at Day 90
Myocardial infarct size measured by LGE-CMR, expressed in relative (percentage of LV mass), calculated as (infarct mass / total LV mass) × 100%.
Time frame: Day 90 (±7 days)
Myocardial Infarct Size (absolute) at Day 6
Myocardial infarct size measured by LGE-CMR, expressed in absolute (grams).
Time frame: Day 6 (±1 day)
Myocardial Infarct Size (relative) at Day 6
Myocardial infarct size measured by LGE-CMR, expressed in relative (percentage of LV mass), calculated as (infarct mass / total LV mass) × 100%.
Time frame: Day 6 (±1 day)
Microvascular Obstruction (MVO)(absolute)
MVO measured by LGE-CMR, expressed in absolute (grams).
Time frame: Day 6 (±1 day), Day 90 (±7 days)
MVO (relative)
MVO measured by LGE-CMR, expressed in relative (percentage of LV mass), calculated as (MVO mass / total LV mass) × 100%.
Time frame: Day 6 (±1 day), Day 90 (±7 days)
Left Ventricular Ejection Fraction (LVEF)
LVEF measured by CMR.
Time frame: Day 6 (±1 day), Day 90 (±7 days)
Left Ventricular End Systolic Volume index (LVESVi)
LVESVi=left ventricular end systolic volume (LVESV)/body surface area (BSA, m²), LVESV measured by CMR.
Time frame: Day 6 (±1 day), Day 90 (±7 days)
Left Ventricular End Diastolic Volume index (LVEDVi)
LVEDVi=left ventricular end diastolic volume (LVDSV)/body surface area (BSA, m²), LVEDV measured by LGE-CMR.
Time frame: Day 6 (±1 day), Day 90 (±7 days)
LVEF at Day 90 Change from Day 6
Change from Day 6 to Day 90.
Time frame: Day 6 (±1 day), Day 90 (±7 days)
LVEDVi at Day 90 Change from Day 6
Change from Day 6 to Day 90.
Time frame: Day 6 (±1 day), Day 90 (±7 days)
LVESVi at Day 90 Change from Day 6
Change from Day 6 to Day 90.
Time frame: Day 6 (±1 day), Day 90 (±7 days)
Biomarkers: N-terminal pro-B-type natriuretic peptide (NT-proBNP)
Time frame: Baseline (pre-dose), Day 2/3/7/30/90
Biomarkers: soluble ST2 (sST2)
Time frame: Baseline (pre-dose), Day 2/3/7/30/90
Biomarkers: high-sensitivity cardiac troponin I (hs-cTnI)
Time frame: Baseline (pre-dose), Day 2/3/7/30/90
Biomarkers: creatine kinase-MB (CK-MB)
Time frame: Baseline (pre-dose), Day 2/3/7/30/90
Biomarkers: high-sensitivity C-reactive protein (hs-CRP)
Time frame: Baseline (pre-dose), Day 2/3/7/30/90
Proportion of participants with persistent MVO at Day 90.
Time frame: Day 90 (±7 days)
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
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.
Time frame: First dose through Day 360
Incidence of Anti-Drug Antibodies (ADA)
Time frame: Baseline and Day 30
Peak Concentration (Cmax)
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.
Time frame: Days 1-7 (post-dose)
Time to Maximum Concentration (Tmax)
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.
Time frame: 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)
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.
Time frame: Days 1-7 (post-dose)
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf)
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.
Time frame: Days 1-7 (post-dose)
Elimination half-life (t1/2)
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.
Time frame: Days 1-7 (post-dose)
Elimination rate constant (λz)
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.
Time frame: Days 1-7 (post-dose)
Clearance (CL)
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.
Time frame: Days 1-7 (post-dose)
Volume of distribution (Vz)
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.
Time frame: Days 1-7 (post-dose)
Left Ventricular Ejection Fraction (LVEF) at 1 Year
LVEF measured by cardiac ultrasound at the Day 360 visit, expressed as a percentage.
Time frame: Day 360 (±14 days)
Quality of Life Assessed by the Minnesota Living with Heart Failure Questionnaire (MLHFQ) at 1 Year
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.
Time frame: Day 360 (±14 days)
Incidence of Major Adverse Cardiovascular Event (MACE)
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.
Time frame: First dose through Day 360
Incidence of New-Onset Major Diseases at 1 Year
New-Onset Major Diseases including clinical events such as heart failure, recurrent myocardial infarction, malignancy, or death from any cause.
Time frame: First dose through Day 360
Plan to share: No
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Beijing Northland Biotech. Co., Ltd.