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

NCT07586865 | Not Yet Recruiting Phase 2

• 1 other identifier: NL005-AMI-IIc
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

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

Keywords

AMI; CMR; cardioprotective

Outcome Measures

Primary Outcomes (2)

• Myocardial Infarct Size (absolute) at Day 90

  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

  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)

Secondary Outcomes (26)

• Myocardial Infarct Size (absolute) at Day 6

  Day 6 (±1 day)

• Myocardial Infarct Size (relative) at Day 6

  Day 6 (±1 day)

• Microvascular Obstruction (MVO)(absolute)

  Day 6 (±1 day), Day 90 (±7 days)

• MVO (relative)

  Day 6 (±1 day), Day 90 (±7 days)

• Left Ventricular Ejection Fraction (LVEF)

  Day 6 (±1 day), Day 90 (±7 days)

Other Outcomes (4)

• Left Ventricular Ejection Fraction (LVEF) at 1 Year

  Day 360 (±14 days)

• Quality of Life Assessed by the Minnesota Living with Heart Failure Questionnaire (MLHFQ) at 1 Year

  Day 360 (±14 days)

• Incidence of Major Adverse Cardiovascular Event (MACE)

  First dose through Day 360

Study Arms (3)

NL005 10 µg/kg Group

EXPERIMENTAL

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)

NL005 20 µg/kg Group

EXPERIMENTAL

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)

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.

Drug: Placebo

Interventions

Recombinant Human Thymosin Beta 4 Injection (NL005) DRUG

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.

NL005 10 µg/kg Group; NL005 20 µg/kg Group

Placebo DRUG

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.

Placebo Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Beijing Northland Biotech. Co., Ltd.: lead

Study Sites (1)

Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)

Beijing, Beijing Municipality, 100037, China

Location

MeSH Terms

Conditions

Anterior Wall Myocardial Infarction; ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Kefei Dou

  Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yue Liu

CONTACT

+86-10-82890893; liuyue@northland-bio.com

Yinjian Sun

CONTACT

+86-10-82890893; sunyinjian@northland-bio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 14, 2026
• Study Start: May 18, 2026
• Primary Completion (Estimated): August 17, 2027
• Study Completion (Estimated): May 17, 2028
• Last Updated: May 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)