Efficacy and Safety of SP-8203 (Otaplimastat) in Patients With Acute Ischemic Stroke Receiving Thrombolytic Standard of Care

Prior treatment

• Patients with a cancer in following conditions: diagnosed within 6 months before the screening time, or any treatment for cancer within the previous 6 months, or with recurrent/ metastatic cancer.
• Pregnant and lactating women. However, Women of Childbearing Potential (WOCBP) can participate in the study only when non-pregnancy is confirmed. Women of Childbearing Potential (WOCBP) is defined as woman who is not definitely menopause and did not receive a surgical contraception.
• Patients who have participated in other clinical trials of other drugs within the past 3 months. However, if they participated in observational studies and did not take drugs, they can participate in this trial.

Other illness

• Patients with systemic allergic diseases or hypersensitivity to specific drugs.
• Patients who were diagnosed with myocardial infarction (MI) within the last 6 months.
• Patients who had arrhythmia causing clinical symptoms such as dyspnea or palpitation within the last 6 months.
• Patients with severe heart failure of New York Heart Association (NYHA) Class III or Class IV.
• Patients with fever (≥ 38℃) or infection signs which require antibiotic therapy at screening.
• Patients with pulmonary diseases (asthma, Chronic Obstruction Pulmonary disease, and active tuberculosis etc.) who have being recently been treated more than 1 month at screening.
• Patients who have undergone hemodialysis and/or treatments due to nephropathies, acute or chronic renal failure at screening.

Lab values

• Patients showing the following abnormal ECG findings in stable condition at Emergency Room:
  • The range of pulse rate - under 55/min or exceed 120/min
  • 2nd or 3rd degree Atrioventricular (AV) block indicated in ECG
  • Congenital or acquired QT syndrome indicated in ECG
  • Pre-excitation syndrome indicated in ECG
• Patients with decreased hemoglobin (Hb\< 10g/dL), decreased platelet count (PLT\< 100,000/mm3) or hematocrit of \<25% in complete blood count.

Other

• Patients who do not consent to use double barrier contraception until 90 days from the first study intervention administration.
• Patients who cannot participate in the study at the discretion of investigators
• Patients who are unable to receive thrombolytic standard of care, rtPA

• Patients with neurologic deficit of ≥ 8 points by National Institute of Health Stroke Scale (NIHSS) score
• Patients with pre-stroke modified Rankin Scale (mRS) must be 0 or 1, which means they were able to carry out all usual duties and activities
• Adults aged ≥19 years and ≤85 years
• Patients who can receive thrombolytic standard of care within 4.5 hours after the onset of early symptoms of acute ischemic stroke
• Patients available for brain Magnetic Resonance Imaging (MRI) scanning
• Patients who consent to participate in this study