Safety and Efficacy Study of Thymosin Beta 4 in Patients With Acute Myocardial Infarction.Infarction
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Low Dose; Middle Dose; High Dose; Placebo
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): 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）; 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）; 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）; 15 subjects will be randomly assigned to the placebo for 7 days
Other intervention name(s): NL005（ Low Dose）; NL005（ Middle Dose）; NL005（High Dose）
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: AMI