[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639639":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":35,"centralContacts":40,"locations":49,"responsibleParty":66,"collaborators":30,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":30,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":30,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":91,"overallStatus":95,"whyStopped":30,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Beijing Northland Biotech. Co., Ltd.","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"NL005 10 µg\u002Fkg Group","EXPERIMENTAL","Participants receive recombinant human thymosin beta 4 injection (NL005) at a dose of 10 µg\u002Fkg 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.",[13],"Drug: Recombinant Human Thymosin Beta 4 Injection (NL005)",{"label":15,"type":10,"description":16,"interventionNames":17},"NL005 20 µg\u002Fkg Group","Participants receive recombinant human thymosin beta 4 injection (NL005) at a dose of 20 µg\u002Fkg 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.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Placebo Group","PLACEBO_COMPARATOR","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.",[23],"Drug: Placebo",[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","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\u002Fkg or 20 µg\u002Fkg, and the total volume is adjusted to 5 mL with compatible diluent before administration.",[9,15],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"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.",[19],[36],{"name":37,"affiliation":38,"role":39},"Kefei Dou","Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)","PRINCIPAL_INVESTIGATOR",[41,46],{"name":42,"role":43,"phone":44,"phoneExt":30,"email":45},"Yue Liu","CONTACT","+86-10-82890893","liuyue@northland-bio.com",{"name":47,"role":43,"phone":44,"phoneExt":30,"email":48},"Yinjian Sun","sunyinjian@northland-bio.com",[50],{"facility":38,"status":30,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Beijing","Beijing Municipality","100037","China","CN",{"type":57,"coordinates":58},"Point",[59,60],116.39723,39.9075,{"lat":60,"lon":59},[63],{"name":37,"role":43,"phone":64,"phoneExt":30,"email":65},"+86-13801032912","drdoukefei@126.com",{"type":67,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100639639","phase-2-recombinant-human-thymosin-beta-4-for-injectionnl005-for-acute-myocardial-infarction-100639639",false,"NCT07586865","Recombinant Human Thymosin Beta 4 for Injection(NL005) for Acute Myocardial Infarction","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","Inclusion Criteria:\n\n* Willing and able to provide written informed consent (by the participant or legally authorized representative)\n* Aged 18 to 75 years old, any sex\n* 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)\n* 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\n* The blocked LAD artery has no visible collateral blood supply from other coronary arteries (Rentrop grade 0)\n* 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)\n* Males and females of childbearing potential must agree to use adequate contraception (such as hormonal or barrier methods, or abstinence) throughout the study\n\nExclusion Criteria:\n\n* Prior history of acute myocardial infarction, chronic total coronary occlusion, coronary thrombolysis, PCI, or coronary artery bypass graft surgery\n* Diagnosis of severe acute heart failure (Killip class III or higher) or chronic heart failure (NYHA functional class III or higher)\n* Severe, uncontrolled arrhythmia that cannot be corrected\n* Presence of aortic dissection\n* Severe liver or kidney dysfunction\n* History of stroke within the past 6 months\n* Current or past diagnosis of any malignancy\n* Blood pressure that remains at or above 180 mmHg systolic and\u002For 110 mmHg diastolic despite adequate antihypertensive treatment\n* History of clinically significant allergic reaction, especially known allergy to protein or biologic drugs\n* Participation in another clinical study within 3 months before screening\n* Unable to undergo cardiac magnetic resonance (CMR) imaging (e.g., due to implanted metal devices, severe claustrophobia, or other contraindications)\n* 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)","ALL","18 Years","75 Years",{"count":79,"type":80},189,"ESTIMATED","INTERVENTIONAL",[83],"PHASE2","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:\n\n* Does NL005 lower the size of permanent heart muscle damage measured by cardiac magnetic resonance (CMR) scan 90 days after treatment?\n* What medical problems do participants have when taking NL005?\n\nResearchers 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.\n\nParticipants will:\n\n* Receive NL005 or placebo through a vein within 4 hours after the PCI procedure, then once a day for 7 days\n* Stay in the hospital for the first week for monitoring, blood draws, and electrocardiograms (heart tracings)\n* Have a CMR scan on Day 6 and Day 90 to measure the size of the heart injury\n* Return to the hospital for checkups on Day 30 and Day 90\n* 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",[86,87,88,89,90],"Acute Myocardial Infarction (AMI)","Acute Myocardial Infarction of Anterior Wall","Acute Myocardial Infarction With ST Elevation","Acute Myocardial Infarction of Left Ventricle","Acute Myocardial Infarction With ST Segment Elevation",[92,93,94],"AMI","CMR","cardioprotective","NOT_YET_RECRUITING","2026-05-08",{"date":98,"type":99},"2026-05-14","ACTUAL",{"date":101,"type":80},"2026-05-18",{"date":103,"type":80},"2028-05-17",{"name":5,"class":6},1]