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

What Was Tested

In this phase 2 trial, researchers set out to test TB-500 (Thymosin Beta-4 fragment) and Thymosin Beta-4 (full length).

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?

It had three arms (groups): one (experimental), one (experimental) and Placebo Group (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

189 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could 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). The blocked LAD artery has no visible collateral blood supply from other coronary arteries (Rentrop grade 0). Males and females of childbearing potential must agree to use adequate contraception (such as hormonal or barrier methods, or abstinence) throughout the study.

The full record lists 7 inclusion and 12 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Because people in this TB-500 (Thymosin Beta-4 fragment) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The TB-500 (Thymosin Beta-4 fragment) group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on TB-500 (Thymosin Beta-4 fragment), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2026-05-18 with completion listed for 2027-08-17.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Myocardial Infarct Size (absolute) at Day 90 (time frame: Day 90 (±7 days)). Myocardial Infarct Size (relative) at Day 90 (time frame: Day 90 (±7 days)).

It also tracked 26 secondary outcomes, for example Myocardial Infarct Size (absolute) at Day 6, Myocardial Infarct Size (relative) at Day 6, Microvascular Obstruction (MVO)(absolute), MVO (relative), Left Ventricular Ejection Fraction (LVEF) and Left Ventricular End Systolic Volume index (LVESVi).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of TB-500 (Thymosin Beta-4 fragment) and Thymosin Beta-4 (full length) in 189 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the TB-500 (Thymosin Beta-4 fragment) compound page and the Thymosin Beta-4 (full length) compound page, all human trials.