['ischemic stroke']
['0.05 ml/kg ddfpe', '0.05 ml/kg placebo', '0.10 ml/kg ddfpe', '0.10 ml/kg placebo', '0.17 ml/kg ddfpe', '0.17 ml/kg placebo']

        Inclusion Criteria:

          -  Ages 18-80 years

          -  Diagnosis of AIS

          -  Body weight ≥ 45 kg

          -  NIHSS between 2 and 20

          -  Patient or legal authorized representative (LAR) must be willing and able to
             understand the study and provide written informed consent

        Exclusion Criteria:

        Currently pregnant or breastfeeding

          -  History of significantly impaired renal or hepatic function

          -  Hemorrhage or hemorrhagic stroke on CT scan

          -  Prior stroke, intracranial surgery, or major head trauma within three months prior to
             enrollment

          -  Pre-stroke modified Rankin Scale (mRS) ≥ 2

          -  Myocardial infarction within six (6) months prior to enrollment

          -  Unstable angina, New York Heart Association (NYHA) Class II or greater congestive
             heart failure

          -  Uncontrolled hypertension (SBP > 180 and/or diastolic blood pressure (DBP) > 110 mmHg)

          -  Known long QT syndrome or QTc > 450 milliseconds (ms) in males and > 470 ms in females

          -  Uncontrolled arrhythmia or history of clinically significant arrhythmia within the
             past six (6) months (except atrial fibrillation)

          -  Clinically significant chronic obstructive pulmonary disease (COPD) or other pulmonary
             condition that is not controlled by medication or requires oxygen frequently or
             continuously

          -  Pneumonia, bronchitis, or other acute respiratory disease

          -  Current anticoagulant therapy except for antiplatelet therapy (aspirin, NSAIDs) and
             prophylactic doses of low molecular weight heparin to prevent deep vein thrombosis.
             Note: tPA administered as part of subjects' therapy for AIS is allowed.

          -  History of allergic reaction attributed to compounds of similar chemical composition
             to DDFPe (see Investigator's Brochure).

          -  Subject has received any investigational drug within thirty (30) days prior to
             enrollment into the study

          -  Inability to comply with the study procedures

          -  History or evidence of any other clinically significant condition that, in the opinion
             of the investigator, might pose a safety risk to subjects or interfere with study
             procedures, evaluation, or completion
      