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Safety Study of PP-007 in Subjects With Acute Ischemic Stroke | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Safety Study of PP-007 in Subjects With Acute Ischemic Stroke

A Randomized, Phase 1, Contemporaneously Controlled, Multicenter Study to Assess the Safety of PP-007 in Subjects With Acute Ischemic Stroke (HEMERA-1)

NCT04677777•Prolong Pharmaceuticals

View on ClinicalTrials.gov

Summary

The HEMERA-1 Extension (Part III) is a prospective, open-label, multicenter study to evaluate safety of two doses of PP-007 in Acute Ischemic Stroke (AIS) subjects receiving Intravenous Thrombolysis (IVT) or mechanical thrombectomy (MT) or IVT+MT as standard of care (SOC). Subjects will receive two doses of PP-007 infusion 24 ± 6 hours apart in addition to the site-specific SOC protocol. PP-007 is PEGylated bovine carboxyhemoglobin and will be administered via IV infusion. The effects on collateral flow, infarct size and functional outcomes will be evaluated.

Detailed Description

Part III of the HEMERA study evaluates safety after extended drug exposure of PP-007 in subjects with AIS. Subjects would receive two PP-007 doses administered 24±6 hours apart, in addition to the site's SOC protocol of IVT or MT or IVT+MT. PP-007 is PEGylated bovine carboxyhemoglobin and will be administered via IV infusion. The effects on collateral flow, infarct size and functional outcomes (NIHSS and mRS) will also be evaluated. Other measures include assessment of plasma concentration of PP-007.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject or subject's LAR has provided informed consent.
•2. ≥18 years of age.
•3. If the patient were to receive MT, patient must have a history of last seen well ≤ 24 hours prior to start of MT
•4. If the patient were to receive IVT, patient must have a history of last seen well ≤ 4.5 hours prior to start of IVT or as per Institution SOC Note: Onset is defined as the time point when symptoms first began, or if unknown, the last time point when the subject reported or was observed having normal (baseline) neurological function.
•5. AIS patient with ASPECTS ≥ 3 to 10
•6. AIS patient with life expectancy of 90 days, as determined by the investigator
•7. Patient with disabling stroke defined as baseline NIHSS ≥ 6 prior to IP administration
•8. mRS ≤ 2 (pre-morbid), prior to onset of symptoms (self-reported or family/caregiver reported)
•9. At the time of stroke, patient must be living in their own home, apartment or seniors lodge where no nursing care/support is required
•10. Subject and caregiver are available for protocol-required follow-up visits
+10 more criteria

Exclusion Criteria

•
•1. ASPECTS \< 3 on NCCT
•2. Multi-arterial territorial strokes (e.g. bilateral, anterior and posterior circulation)
•3. Evidence of symptomatic intracranial hemorrhage, including subarachnoid hemorrhage, on initial CTA/CTP, or history of intracranial hemorrhage within the last 30 days.
•4. Pre-existing neurological or psychiatric disease that would confound neurological or functional evaluations in the opinion of the Investigator.
•5. A seizure at stroke onset that precludes obtaining an accurate screening NIHSS and mRS assessment
•6. Clinical history, past imaging, or clinical judgment suggests that the intracranial occlusion is chronic
•7. History of severe head injury within 90 days of Baseline with residual neurological deficit at the time of AIS.
•8. Clinically significant heart disease including:
•a. Symptoms or ECG evidence of acute myocardial infarction or unstable angina. b. Cardiac arrhythmia associated with hemodynamic instability. c. Heart failure (New York Heart Association Class III or IV) or known ejection fraction \<30%.
+38 more criteria

Locations (8)

Baptist Health Research Institute

Jacksonville, Florida, United States

Baptist Health Miami Cardiac & Vascular Institute (MCVI)

Miami, Florida, United States

Emory University School of Medicine

Atlanta, Georgia, United States

Saint Luke's Hospital

Kansas City, Missouri, United States

Mercy Health - St. Vincent Medical Center

Toledo, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Oregon Stroke Center at Oregon Health & Science University (OHSU)

Portland, Oregon, United States

UPMC Stroke Institute

Pittsburgh, Pennsylvania, United States

Key Dates

Start Date

April 24, 2024

Primary Completion Date

February 20, 2025

Completion Date

February 20, 2025

Last Updated

November 14, 2025

Enrollment

ACTUAL participants

Conditions

Acute Ischemic Stroke

Interventions

PP-007 (Two doses administered 24±6 hours apart) + SOC (IVT or MT or IVT+MT)

BIOLOGICAL

Tenecteplase Before Interhospital Transfer for EVT in Acute Anterior Circulation LVO at 4.5-24 Hours

NCT07253181

Acute Ischemic StrokeLarge Vessel Occlusion+1 more

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RECRUITINGPHASE2/PHASE3

Optimizing Reperfusion to Improve Outcomes and Neurologic Function

NCT06990867

Acute Ischemic Stroke

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety Study of PP-007 in Subjects With Acute Ischemic Stroke

Inclusion Criteria

Exclusion Criteria

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