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

Who is this study for? Patients with Stroke
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Florida
Baptist Health Research Institute
RECRUITING
Jacksonville
Baptist Health Miami Cardiac & Vascular Institute (MCVI)
RECRUITING
Miami
Georgia
Emory University School of Medicine
RECRUITING
Atlanta
Missouri
Saint Luke's Hospital
RECRUITING
Kansas City
Ohio
Mercy Health - St. Vincent Medical Center
RECRUITING
Toledo
Oklahoma
University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Oregon
Oregon Stroke Center at Oregon Health & Science University (OHSU)
RECRUITING
Portland
Pennsylvania
UPMC Stroke Institute
NOT_YET_RECRUITING
Pittsburgh
Contact Information
Primary
Kirsten Gruis, MD
kgruis@prolongpharma.com
(734) 604-1172
Backup
Ronald Jubin, PhD
rjubin@prolongpharma.com
(908) 315-5762
Time Frame
Start Date: 2024-04-24
Estimated Completion Date: 2025-02-28
Participants
Target number of participants: 24
Treatments
Experimental: PP-007 along with Standard of care (SOC)
The study has only single arm, wherein, patients will receive two doses of PP-007 (24 ± 6 hours apart), along with the Standard-of-care (SOC) as per the site's medical practice. SOC is defined as Intravenous thrombolysis (IVT) or Mechanical Thrombectomy (MT) or both (IVT+MT).
Related Therapeutic Areas
Sponsors
Leads: Prolong Pharmaceuticals

This content was sourced from clinicaltrials.gov