Safety Study of PP-007 in Subjects With Acute Ischemic Stroke
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Ischemic Stroke
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Contemporaneously controlled, blinded safety studyMasking: Double (Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The study will evaluate the safety of a single administration of PP-007 in patients admitted to a hospital for Acute Ischemic Stroke. PP-007 is pegylated bovine carboxyhemoglobin and will be administered via IV infusion. The effects on collateral flow, infarct size and functional outcome will also b...
The study will evaluate the safety of a single administration of PP-007 in patients admitted to a hospital for Acute Ischemic Stroke. PP-007 is pegylated bovine carboxyhemoglobin and will be administered via IV infusion. The effects on collateral flow, infarct size and functional outcome will also be evaluated. Patients will be randomized to either standard of care excluding tPA, or PP-007. Patients may also receive thrombectomy. Other measures include assessment of plasma concentration of PP-007.
Tracking Information
- NCT #
- NCT04677777
- Collaborators
- Not Provided
- Investigators
- Study Director: Prayag Shah, MD, MBA Prolong Pharmaceuticals, LLC
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