Acute Myocardial Infarction (AMI)Phase 2NCT07586865
Recombinant Human Thymosin Beta 4 for Injection(NL005) for Acute Myocardial Infarction
A Phase 2 study testing Recombinant Human Thymosin Beta 4 Injection (NL005) in people with Acute Myocardial Infarction (AMI) and Acute Myocardial Infarction of Anterior Wall, run by Beijing Northland Biotech. Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myocardial Infarction (AMI), Acute Myocardial Infarction of Anterior Wall, Acute Myocardial Infarction With ST Elevation
- What is being tested?
- Recombinant Human Thymosin Beta 4 Injection (NL005)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 189 participants
- Where
- 1 siteChina
- Study dates
- 18 May 2026to 17 May 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)
Beijing, Beijing Municipality, 100037
Kefei Dou, +86-13801032912, drdoukefei@126.com
About this study
Official title: 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?
Read more
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
Read the detailed description
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.
- 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
- Being tested
- Recombinant Human Thymosin Beta 4 Injection (NL005), Placebo
- Keywords
- AMI, CMR, cardioprotective
- Medical subject headings
- Anterior Wall Myocardial Infarction, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboDrug
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial Infarct Size (absolute) at Day 90
Myocardial infarct size measured by late gadolinium enhancement cardiac magnetic resonance (LGE-CMR), expressed in absolute (grams).
Measured: 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%.
Measured: Day 90 (±7 days)
Secondary outcomes (26)
Myocardial Infarct Size (absolute) at Day 6
Myocardial infarct size measured by LGE-CMR, expressed in absolute (grams).
Measured: 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%.
Measured: Day 6 (±1 day)
Microvascular Obstruction (MVO)(absolute)
MVO measured by LGE-CMR, expressed in absolute (grams).
Measured: 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%.
Measured: Day 6 (±1 day), Day 90 (±7 days)
Left Ventricular Ejection Fraction (LVEF)
LVEF measured by CMR.
Measured: 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.
Measured: 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.
Measured: Day 6 (±1 day), Day 90 (±7 days)
LVEF at Day 90 Change from Day 6
Change from Day 6 to Day 90.
Measured: Day 6 (±1 day), Day 90 (±7 days)
LVEDVi at Day 90 Change from Day 6
Change from Day 6 to Day 90.
Measured: Day 6 (±1 day), Day 90 (±7 days)
LVESVi at Day 90 Change from Day 6
Change from Day 6 to Day 90.
Measured: Day 6 (±1 day), Day 90 (±7 days)
Biomarkers: N-terminal pro-B-type natriuretic peptide (NT-proBNP)
Measured: Baseline (pre-dose), Day 2/3/7/30/90
Biomarkers: soluble ST2 (sST2)
Measured: Baseline (pre-dose), Day 2/3/7/30/90
Biomarkers: high-sensitivity cardiac troponin I (hs-cTnI)
Measured: Baseline (pre-dose), Day 2/3/7/30/90
Biomarkers: creatine kinase-MB (CK-MB)
Measured: Baseline (pre-dose), Day 2/3/7/30/90
Biomarkers: high-sensitivity C-reactive protein (hs-CRP)
Measured: Baseline (pre-dose), Day 2/3/7/30/90
Proportion of participants with persistent MVO at Day 90.
Measured: 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.
Measured: First dose through Day 360
Incidence of Anti-Drug Antibodies (ADA)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Days 1-7 (post-dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start18 May 2026 (estimated)
- Primary completion17 Aug 2027 (estimated)
- Study completion17 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial Infarction (AMI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 189 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Northland Biotech. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kefei Dou, Principal investigator, Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07586865
- Sponsor's protocol ID
- NL005-AMI-IIc
- Status last verified
- Apr 2026
- First submitted
- 30 Apr 2026
- Last updated
- 14 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07586865
- Acronym / sponsor ID
- NL005-AMI-IIc
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 189 participants (estimated)
- Lead sponsor
- Beijing Northland Biotech. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 May 2026 (estimated)
- Primary completion
- 17 Aug 2027 (estimated)
- Study completion
- 17 May 2028 (estimated)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NL005 10 µg/kg Group | Experimental | Drug: Recombinant Human Thymosin Beta 4 Injection (NL005)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. |
| NL005 20 µg/kg Group | Experimental | 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. |
| Placebo Group | Placebo comparator | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | NL005 10 µg/kg Group, NL005 20 µg/kg Group |
| PlaceboThe 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. | Drug | Placebo Group |
Primary outcome
Myocardial Infarct Size (absolute) at Day 90
Time frame: 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
Time frame: 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%.
26 secondary outcomes
Myocardial Infarct Size (absolute) at Day 6
Time frame: Day 6 (±1 day)
Myocardial Infarct Size (relative) at Day 6
Time frame: Day 6 (±1 day)
Microvascular Obstruction (MVO)(absolute)
Time frame: Day 6 (±1 day), Day 90 (±7 days)
MVO (relative)
Time frame: Day 6 (±1 day), Day 90 (±7 days)
Left Ventricular Ejection Fraction (LVEF)
Time frame: Day 6 (±1 day), Day 90 (±7 days)
Left Ventricular End Systolic Volume index (LVESVi)
Time frame: Day 6 (±1 day), Day 90 (±7 days)
Left Ventricular End Diastolic Volume index (LVEDVi)
Time frame: Day 6 (±1 day), Day 90 (±7 days)
LVEF at Day 90 Change from Day 6
Time frame: Day 6 (±1 day), Day 90 (±7 days)
LVEDVi at Day 90 Change from Day 6
Time frame: Day 6 (±1 day), Day 90 (±7 days)
LVESVi at Day 90 Change from Day 6
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)
Time frame: First dose through Day 360
Incidence of Anti-Drug Antibodies (ADA)
Time frame: Baseline and Day 30
Peak Concentration (Cmax)
Time frame: Days 1-7 (post-dose)
Time to Maximum Concentration (Tmax)
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)
Time frame: Days 1-7 (post-dose)
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf)
Time frame: Days 1-7 (post-dose)
Elimination half-life (t1/2)
Time frame: Days 1-7 (post-dose)
Elimination rate constant (λz)
Time frame: Days 1-7 (post-dose)
Clearance (CL)
Time frame: Days 1-7 (post-dose)
Volume of distribution (Vz)
Time frame: Days 1-7 (post-dose)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kefei Dou principal investigator
Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant Human Thymosin Beta 4 Injection (NL005) in people with Acute Myocardial Infarction (AMI) and Acute Myocardial Infarction of Anterior Wall, run by Beijing Northland Biotech. Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yue Liu (+86-10-82890893, liuyue@northland-bio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial Infarct Size (absolute) at Day 90 (time frame: Day 90 (±7 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.