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TB-500

Thymosin Beta-4, TB4, Tβ4

Quick Stats
Studies 6
Trials 21
Completed PHASE2 INTERVENTIONAL NCT05485818

Safety and Efficacy Study of Thymosin Beta 4 in Patients With Acute Myocardial Infarction.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.60 subjects eligible for inclusion will be randomly assigned to either a low-dose (0.25ug/kg) medium-dose (0.5ug/kg) high-dose (2.0ug/kg) experimental drug group or a control group (placebo) at a ratio of 1:1:1:1.After randomization, subjects received the experimental drug or placebo once a day, intravenously, on day 2 to 7, 12 hours and 4 hours after PCI.Ninety days after PCI were observed.

Detailed Description

Subjects underwent cardiovascular magnetic resonance imaging (CMR) on the 90th day after PCI, which was used to evaluate the myocardial salvage index myocardial infarction area, microvascular occlusion area, left ventricular ejection fraction (LVEF), left ventricular end-systolic volume (LVESV), and left ventricular end-diastolic volume (LVEDV).Echocardiography was performed on the 5th and the 90th day after PCI to evaluate the left indoor diameter (LV) and left atrial diameter (LA) of LVEF. Physical examination routine blood coagulation function was performed on the 30th and 90th day after PCI in the screening period (pre-screening results were acceptable);Electrocardiogram (ECG) was performed on the 30th and the 90th day after PCI on the 2nd day after the first administration;During the screening period (results before screening are acceptable), vital signs should be measured from day 1 to day 7 after PCI (during each dose, vital signs should be measured twice on day 7, including before and after administration), on day 30 and day 90;Blood biochemical examinations were performed from day 2 to day 4, day 7, day 30, and day 90 after PCI before the first administration;Creatine kinase isoenzyme (CK-MB) hypersensitive 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 detected on day 2, day 3, day 4 and day 7 after PCI before the first administration.Tumor markers were detected and immunogenicity blood samples were collected 30 days after PCI before the first administration.Routine urinalysis was performed 90 days after PCI before the first administration;Adverse drug events and cardiovascular events were continuously recorded during the trial.

Interventions

Name: Low Dose
Type: DRUG
Description: 12±4 hours after PCI: 0.25 ug/kg Recombinant Human Thymosin β4 (intravenous injection),Day2-Day7 after PCI:0.25 ug/kg Recombinant Human Thymosin β4 (intravenous injection)
Name: Middle Dose
Type: DRUG
Description: 12±4 hours after PCI: 0.5 ug/kg Recombinant Human Thymosin β4 (intravenous injection),Day2-Day7 after PCI:0.5 ug/kg Recombinant Human Thymosin β4 (intravenous injection)
Name: High Dose
Type: DRUG
Description: 12±4 hours after PCI: 2.0 ug/kg Recombinant Human Thymosin β4 (intravenous injection),Day2-Day7 after PCI:2.0 ug/kg Recombinant Human Thymosin β4 (intravenous injection)
Name: Placebo
Type: OTHER
Description: 15 subjects will be randomly assigned to the placebo for 7 days

Primary Outcomes

Measure: Change of myocardial infarction area on Day 5 and day 90 after PCI
TimeFrame: Day 5、Day 90
Description: Change of myocardial infarction area on Day 5 and day 90 after PCI. Myocardial infarction area day 5 and day 90 after PCI,and the change on day 90 compared to day 5. Myocardial infarction size was evaluated by late gadolinium enhanced cardiac magnetic resonance (LGE-CMR) imaging.

Trial Information

NCT ID

NCT05485818

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

Beijing Northland Biotech. Co., Ltd.

Last Updated

December 15, 2025