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

NCT04677777 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-11-14

No results posted yet for this study

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.

Conditions

  • Acute Ischemic Stroke

Interventions

BIOLOGICAL

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

PP-007 is PEGylated carboxyhemoglobin. Eligible patients will receive two doses of PP-007 (at least 24 hours apart) to evaluate extended drug exposure along with MT and/or IVT (individually or together) as SOC to evaluate safety in AIS patients.

Sponsors & Collaborators

  • Prolong Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Kirsten Gruis, MD · Prolong Pharmaceuticals, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-24
Primary Completion
2025-02-20
Completion
2025-02-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04677777 on ClinicalTrials.gov