A Randomized, Phase 1, Contemporaneously Controlled, Multicenter Study to Assess the Safety of PP-007 in Subjects With Acute Ischemic Stroke (HEMERA-1)
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.
• Subject or subject's LAR has provided informed consent.
• ≥18 years of age.
• If the patient were to receive MT, patient must have a history of last seen well ≤ 24 hours prior to start of MT
• 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.
• AIS patient with ASPECTS ≥ 3 to 10
• AIS patient with life expectancy of 90 days, as determined by the investigator
• Patient with disabling stroke defined as baseline NIHSS ≥ 6 prior to IP administration
• mRS ≤ 2 (pre-morbid), prior to onset of symptoms (self-reported or family/caregiver reported)
• At the time of stroke, patient must be living in their own home, apartment or seniors lodge where no nursing care/support is required
⁃ Subject and caregiver are available for protocol-required follow-up visits
⁃ Contraception and pregnancy:
• Male subjects, and females of childbearing potential (subjects and female partners of male subjects who are ovulating, premenopausal, and not surgically sterile) must use a highly effective method of contraception consistently and correctly during study participation and up to 90 days following PP-007 infusion.
∙ Highly effective methods of contraception are those that, either alone or in combination, result in a failure rate of \<1% per year when used consistently and correctly, including:
⁃ i. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (i.e., oral, intravaginal, or transdermal).
⁃ ii. Progesterone-only hormonal contraception associated with inhibition of ovulation (i.e., oral, injectable, or implantable).
⁃ iii. Intrauterine device, intrauterine hormone-releasing system, or bilateral tubal occlusion.
⁃ iv. Male sterilization performed more than six months prior to Screening. v. Sexual abstinence. c. Female subjects of non-childbearing potential must be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks before Screening) or postmenopausal, defined as spontaneous amenorrhea for at least 12 months.
⁃ d. Male subjects must abstain from sperm donation during study participation and up to 90 days following PP-007 infusion.
⁃ e. Female subjects of childbearing potential must have negative results for the pregnancy test at Screening/Baseline.
‣ AIS patient with ASPECTS ≥ 3 to 10