Acute Myocardial Infarction (AMI)Acute Myocardial Infarction of Anterior WallAcute Myocardial Infarction With ST ElevationAcute Myocardial Infarction of Left VentricleAcute Myocardial Infarction With ST Segment Elevation
Investigational drug(s) / intervention(s)
Recombinant Human Thymosin Beta 4 Injection (NL005)Placebo
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: 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.
Study summary
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
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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)
Primary outcome measure(s)
Myocardial Infarct Size (absolute) at Day 90 — Day 90 (±7 days) Myocardial infarct size measured by late gadolinium enhancement cardiac magnetic resonance (LGE-CMR), expressed in absolute (grams).
Myocardial Infarct Size (relative) at Day 90 — 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%.
Trial sites (1)
Facility
City
Region
Status
Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)
Beijing
Beijing Municipality
More Beijing Northland Biotech. Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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