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

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.

Timeline

Start

2024-04-24

Primary completion

2025-02-20

Completion

2025-02-20

Publications

• Linfante I, Clark W, Haussen DC, Hanel R, Reshi R, Dabus G, Jubin R, Roshan MP, Belnap S, Nguyen TN, Grotta J, Wicks R, Cipolla MJ, Liebeskind DS, Nogueira RG. HEMERA 1 CarboxyHEMoglobin oxygEn delivery for Revascularization in Acute Stroke: A Prospective, Randomized Phase 1 Clinical Trial. Stroke Vasc Interv Neurol. 2024 Apr 23;4(4):e001246. doi: 10.1161/SVIN.123.001246. eCollection 2024 Jul.

Drugs

Indications