NCT04677777

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Prolong Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-04-24
• Primary completion: 2025-02-20
• Completion: 2025-02-20
• First posted: 2020-12-21
• Last updated: 2025-11-14

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study