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TB-500

Thymosin Beta-4, TB4, Tβ4

Quick Stats
Studies 6
Trials 21
Completed PHASE2 INTERVENTIONAL NCT05984134

Efficacy and Safety Study of Thymosin Beta 4 in Patients With Acute Myocardial Infarction

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

A multicenter randomized double-blind placebo parallel control design was used in this study. The 90 participants were randomly assigned to placebo, 0.5μg/kg dose group, and 1.0μg/kg dose group in a ratio of 1:1:1. After randomization, subjects received the trial drug or placebo intravenously within 12 hours and on days 2 to 7 after PCI. The patients were observed 90 days after PCI.

Detailed Description

Cardiovascular magnetic resonance imaging (CMR) was performed on day 5 and day 90 after PCI to evaluate myocardial infarction size, microvascular obstruction area, left ventricular ejection fraction (LVEF), left ventricular end-systolic volume (LVESV), and left ventricular end-diastolic volume (LVEDV). Physical examination, blood routine examination, and coagulation function examination were performed before the first dose, on the 7th, 30th, and 90th day after PCI. The examination before the first dose was conducted to accept the examination results from the current onset to the first dose.Electrocardiogram (ECG) was performed before the first dose, day 2, day 7, day 30, and day 90 after PCI, and the test results from the period after PCI to the first dose were received. Vital signs were examined before the first dose, day 1 to day 7, day 30, and day 90 after PCI, and the results of the examination from the first onset to the first dose were accepted during the examination before the first dose. Blood biochemical tests were performed before the first dose, from day 2 to day 4, day 7, day 30, and day 90 after PCI. The results of the examinations from the first onset to the first dose were accepted during the examination before the first dose. High-sensitivity troponin I(hs-cTnI) or troponin I(cTnI) and amino-terminal B-type natriuretic peptide precursor (NT-proBNP) or B-type natriuretic peptide (BNP) were tested before first administration and on days 2, 3, 4, and 7 after PCI. Examination results from the time after PCI to the time before initial administration; Creatine kinase isoenzyme (CK-MB) tests were performed before the first dose, 12 hours after the first dose, day 2 (if it coincided with 12 hours after the first dose, no repeat blood collection was required), day 3, and day 4. The test results from the period after PCI to the period before the first dose were accepted. Tumor markers were detected and immunogenic blood samples were collected before the first dose and on the 30th day after PCI. The tumor markers were examined before the first dose. Urine routine examination was performed before the first dose and on the 90th day after PCI. The examination before the first dose accepted the examination results from the onset of the disease to the first dose. Drug combinations, adverse events, and cardiovascular events were recorded during the trial.

Interventions

Name: NL005 Middle Dose
Type: DRUG
Description: Patients in this treatment group will receive NL005 for 0.5 ug/kg respective.Continuous administration for 7 days.
Name: NL005 High Dose
Type: DRUG
Description: Patients in this treatment group will receive NL005 for 1.5 ug/kg respective.Continuous administration for 7 days.
Name: Placebo
Type: DRUG
Description: 30 subjects will be randomly assigned to the placebo for 7 days

Primary Outcomes

Measure: Percentage change of myocardial infarction area
TimeFrame: Day 5、Day 90
Description: The percentage of myocardial infarction area was defined as the percentage of CMR delayed enhancement area in the entire left ventricular myocardium as measured by plane geometry of computer-assisted enhanced myocardium.Percentage change of myocardial infarction size =D5 percentage of myocardial infarction size -D90 percentage of myocardial infarction size

Trial Information

NCT ID

NCT05984134

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

Beijing Northland Biotech. Co., Ltd.

Last Updated

December 15, 2025