NCT05984134

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

Efficacy and Safety of Recombinant Human Thymosin β4(NL005) for Injection in Patients With Acute Myocardial Infarction: a Phase IIb Clinical Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Beijing Northland Biotech. Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myocardial Infarction

Interventions

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

Timeline

• Start date: 2022-07-15
• Primary completion: 2023-05-26
• Completion: 2023-05-29
• First posted: 2023-08-09
• Last updated: 2024-06-21

Locations

1 site across 1 country: China