A Phase 1b in Patients With Acute Ischemic Stroke


Phase 1 Results N/A

Eligibility Criteria

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