Acute Ischemic StrokePhase 1HEMERA-1NCT04677777
Safety Study of PP-007 in Subjects With Acute Ischemic Stroke
A Phase 1 study testing PP-007 (Two doses administered 24±6 hours apart) + SOC (IVT or MT or IVT+MT) in people with Acute Ischemic Stroke, run by Prolong Pharmaceuticals at 8 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- PP-007 (Two doses administered 24±6 hours apart) + SOC (IVT or MT or IVT+MT)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 8 sitesUnited States
- Study dates
- 24 Apr 2024to 20 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 20Show fewer
- 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:
- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (i.e., oral, intravaginal, or transdermal).
- Progesterone-only hormonal contraception associated with inhibition of ovulation (i.e., oral, injectable, or implantable).
- Intrauterine device, intrauterine hormone-releasing system, or bilateral tubal occlusion.
- 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.
- Male subjects must abstain from sperm donation during study participation and up to 90 days following PP-007 infusion.
- Female subjects of childbearing potential must have negative results for the pregnancy test at Screening/Baseline.
- AIS patient with ASPECTS ≥ 3 to 10
Who cannot join
- <!-- -->
- ASPECTS < 3 on NCCT
- Multi-arterial territorial strokes (e.g. bilateral, anterior and posterior circulation)
- Evidence of symptomatic intracranial hemorrhage, including subarachnoid hemorrhage, on initial CTA/CTP, or history of intracranial hemorrhage within the last 30 days.
- Pre-existing neurological or psychiatric disease that would confound neurological or functional evaluations in the opinion of the Investigator.
- A seizure at stroke onset that precludes obtaining an accurate screening NIHSS and mRS assessment
Show all 51Show fewer
- Clinical history, past imaging, or clinical judgment suggests that the intracranial occlusion is chronic
- History of severe head injury within 90 days of Baseline with residual neurological deficit at the time of AIS.
- Clinically significant heart disease including:
- Symptoms or ECG evidence of acute myocardial infarction or unstable angina. b. Cardiac arrhythmia associated with hemodynamic instability. c. Heart failure (New York Heart Association Class III or IV) or known ejection fraction <30%.
- ECG with second- or third-degree heart block in the absence of a permanent pacemaker.
- Refractory BP (systolic >200 and/or diastolic >120 mmHg).
- Confirmed diagnosis of septic embolus or bacterial endocarditis within the past six months.
- Aortic dissection.
- Contraindication to radiographic imaging procedures including:
- Known hypersensitivity to radiographic contrast agents. b. Known renal insufficiency precluding repeated contrast administration.
- Prior treatment (within the last 30 days) or planned concurrent treatment with an investigational medication or device.
- Blood glucose <50 mg/dL (2.78 mmol) or >400 mg/dL (22.20 mmol) that is not responsive to appropriate treatment at Baseline.
- Known bleeding disorder (e.g., coagulopathy or thrombocytopenia).
- Platelet count <50,000/μL at Baseline b. Any anticoagulants within the previous 48 hours that leads to Prothrombin Time (International Normalization Ratio [INR]) ≥2.0 and/or activated partial thromboplastin time (aPTT) ≥40 sec at baseline.
- Any dual antiplatelet agents (e.g., aspirin plus clopidogrel) within the previous 48 hours that leads to Prothrombin Time (INR ≥ 2.0 and or aPTT ≥ 40 sec at baseline)
- Known history or current evidence of renal or hepatic disease including:
- Documented renal insufficiency (serum creatinine >3.0 × ULN).
- History of liver disease (i.e., alanine transaminase [ALT] and/or Aspartate transaminase (AST) >2 × ULN and/or conjugated bilirubin >1.5 mg/dL).
- Note: A subject without history or current evidence of renal or hepatic disease does not require creatinine, ALT, AST, or bilirubin results to be available prior to enrollment.
- 17. Mass effect or intracranial mass on NCCT defined as:
- Significant mass effect with midline shift ≥8 mm.
- Evidence of intracranial mass (except for small non-clinically significant meningioma based on the Investigator's discretion).
- 18. Employee of Prolong Pharmaceuticals or its designated clinical research organization or an employee or relative of the Investigator.
- 19. Any condition or situation which may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study in the opinion of the Investigator.
- 20. Intracranial neoplasm, arteriovenous malformation, or aneurysm 21. Participation in another clinical trial investigating a drug, medical device, or a medical procedure in the 30 days preceding study inclusion Note: LVO and/or SVO will be allowed as long as the respective study subject meets the inclusion and exclusion criteria defined above.
- Inclusion/Exclusion criteria for 2nd PP-007 dose: Prior to administering the second dose of PP-007, the subject, must be evaluated for the following:
- Multi-arterial territorial strokes (e.g. bilateral, anterior and posterior circulation)
- Evidence of symptomatic intracranial hemorrhage, including subarachnoid hemorrhage, on NCCT or CTA/CTP.
- Clinically significant heart disease including:
- Symptoms or ECG evidence of acute myocardial infarction or unstable angina. b. Cardiac arrhythmia associated with hemodynamic instability. c. Heart failure (New York Heart Association Class III or IV) or known ejection fraction <30%.
- ECG with second- or third-degree heart block in the absence of a permanent pacemaker.
- 4. Refractory BP (systolic >200 and/or diastolic >120 mmHg). 5. Confirmed diagnosis of septic embolus or bacterial endocarditis. 6. Aortic dissection. 7. Blood glucose <50 mg/dL (2.78 mmol) or >400 mg/dL (22.20 mmol). 8. Known bleeding disorder (e.g., coagulopathy or thrombocytopenia).
- Platelet count <50,000/μL at Baseline b. For 2nd dose, patient fully anti-coagulated (heparinized) will be excluded (DBT prophylaxis is allowed) 9. Evidence of renal or hepatic disease including:
- Documented renal insufficiency (serum creatinine >3.0 × ULN).
- Documented liver disease (i.e., alanine transaminase [ALT] and/or Aspartate transaminase (AST) >2 × ULN and/or conjugated bilirubin >1.5 mg/dL).
- Note: A subject without history or current evidence of renal or hepatic disease does not require creatinine, ALT, AST, or bilirubin results to be available prior to enrollment.
- 10. Mass effect or intracranial mass on NCCT defined as:
- Significant mass effect with midline shift ≥8 mm. b. Evidence of intracranial mass (except for small non-clinically significant meningioma based on the Investigator's discretion).
- 11. Intracranial neoplasm, arteriovenous malformation, or aneurysm 12. Any condition or situation which may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study in the opinion of the Investigator.
- Parenchymal hematoma (PH-1 and PH-2)
- Symptomatic intracranial hemorrhage
- Hemicraniectomy
- Midline shift ≥ 8 mm
- Mass effect
- Significant cerebral edema Note: LVO and/or SVO will be allowed as long as the respective study subject meets the inclusion and exclusion criteria defined above. The decision to administer the 2nd dose will be based on subject's safety and PI's discretion.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Emory University School of Medicine
Atlanta, Georgia, 30303
Baptist Health Research Institute
Jacksonville, Florida, 32207
Saint Luke's Hospital
Kansas City, Missouri, 64111
Baptist Health Miami Cardiac & Vascular Institute (MCVI)
Miami, Florida, 33176
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
UPMC Stroke Institute
Pittsburgh, Pennsylvania, 15213
Oregon Stroke Center at Oregon Health & Science University (OHSU)
Portland, Oregon, 97239
Mercy Health - St. Vincent Medical Center
Toledo, Ohio, 43608
About this study
Official title: 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.
Read the 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
- Being tested
- PP-007 (Two doses administered 24±6 hours apart) + SOC (IVT or MT or IVT+MT)
- Keywords
- Stroke, Thrombectomy, Intravenous Thrombolysis, NIHSS, mRS, ASPECTS
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PP-007 (Two doses administered 24±6 hours apart) + SOC (IVT or MT or IVT+MT)Biological
Also called Sanguinate
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.
| Study group | Role | What they receive |
|---|---|---|
| PP-007 along with Standard of care (SOC) | Experimental | 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). Receives: Biological: PP-007 (Two doses administered 24±6 hours apart) + SOC (IVT or MT or IVT+MT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vital Signs
Change from baseline in systolic and diastolic blood pressure in mm Hg
Measured: 90 days
Heart-rate
Change from baseline in heart-rate in bpm
Measured: 90 days
12-lead ECG
Change from baseline in msec for QT, QTc, RR and PR intervals
Measured: 90 days
Clinically significant change from baseline in Biochemical, hematological, coagulation and urinalysis measures
Number of subjects with clinically significant change from baseline in Biochemical, hematological, coagulation and urinalysis measures
Measured: 90 days
Cardiovascular Adverse Events (MI, myocardial injury, hypertension. hypertensive crisis, pulmonary hypertension) & Mortality
Number of occurrences
Measured: 90 days
Symptomatic intracranial hemorrhage
Incidence of symptomatic intracranial hemorrhage, number of occurrences
Measured: 90 days
Major Bleeding incidences
Number of occurrences
Measured: 90 days
Adverse Events
Presence or absence
Measured: 90 days
Bleeding requiring surgical intervention
Number of occurrences
Measured: 90 days
Bleeding requiring intravenous vasoactive drugs
Number of occurrences
Measured: 90 days
Intracranial hemorrhage
Number of occurrences
Measured: 90 days
Intraocular bleed compromising vision
Number of occurrences
Measured: 90 days
Fatal bleeding
Number of occurrences
Measured: 90 days
AESI, Blood pressure
Number of events of systolic blood pressure [SBP] >220 mmHg or diastolic blood pressure [DBP] >120 mmHg
Measured: 90 days
AESI, Liver panel
Number of events of Liver enzymes elevation >3.0 × Baseline or upper limit of normal [ULN]
Measured: 90 days
AESI, neurological deterioration
Number of occurrences of Neurological deterioration (≥4-point increase from Baseline in National Institutes of Health Stroke Scale (NIHSS).
Measured: 90 days
Secondary outcomes (6)
Clinical Activity, ASITN collateral score
American Society of Interventional and Therapeutic Neuroradiology collateral score (CT Change from baseline in angiography [CTA] Score 0-4 pre- and post-dose
Measured: 90 days
Clinical Activity
Non-contrast computed tomography (NCCT 24 hours)
Measured: 90 days
Clinical Activity, NIHSS and mRS
Change from baseline in NIHSS and mRS score
Measured: 90 days
Plasma Concentration of PP007
Plasma PP007 concentration in mg/mL at end of infusion and 24 h post infusion
Measured: 24 hours
Clinical Activity, eTICI
Change from baseline in Expanded treatment in cerebral infarction (eTICI) score 2b or 3 post-thrombectomy change
Measured: 90 days
Clinical Activity, infarct growth
Predicted infarct growth for CT/CTP and collateral score
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start24 Apr 2024
- Primary completion20 Feb 2025
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Contemporaneously controlled, open-label safety study
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prolong Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kirsten Gruis, MD, Study director, Prolong Pharmaceuticals, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677777
- Sponsor's protocol ID
- PIS007-101
- Acronym
- HEMERA-1
- Status last verified
- Nov 2025
- First submitted
- 11 Nov 2020
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
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.
PubMed 41585378
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Phase 1, Contemporaneously Controlled, Multicenter Study to Assess the Safety of PP-007 in Subjects With Acute Ischemic Stroke (HEMERA-1)
- ClinicalTrials.gov ID
- NCT04677777
- Acronym / sponsor ID
- HEMERA-1 / PIS007-101
- Conditions
- Acute Ischemic Stroke
- Keywords
- Stroke, Thrombectomy, Intravenous Thrombolysis, NIHSS, mRS, ASPECTS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Prolong PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 21 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Contemporaneously controlled, open-label safety study
| Arm | Type | Receives |
|---|---|---|
| PP-007 along with Standard of care (SOC) | Experimental | Biological: PP-007 (Two doses administered 24±6 hours apart) + SOC (IVT or MT or IVT+MT)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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (51 listed)
- <!-- -->
- ASPECTS < 3 on NCCT
- Multi-arterial territorial strokes (e.g. bilateral, anterior and posterior circulation)
- Evidence of symptomatic intracranial hemorrhage, including subarachnoid hemorrhage, on initial CTA/CTP, or history of intracranial hemorrhage within the last 30 days.
- Pre-existing neurological or psychiatric disease that would confound neurological or functional evaluations in the opinion of the Investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PP-007 (Two doses administered 24±6 hours apart) + SOC (IVT or MT or IVT+MT)Also: SanguinatePP-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. | Biological | PP-007 along with Standard of care (SOC) |
Primary outcome
Vital Signs
Time frame: 90 days
Change from baseline in systolic and diastolic blood pressure in mm Hg
Heart-rate
Time frame: 90 days
Change from baseline in heart-rate in bpm
12-lead ECG
Time frame: 90 days
Change from baseline in msec for QT, QTc, RR and PR intervals
Clinically significant change from baseline in Biochemical, hematological, coagulation and urinalysis measures
Time frame: 90 days
Number of subjects with clinically significant change from baseline in Biochemical, hematological, coagulation and urinalysis measures
Cardiovascular Adverse Events (MI, myocardial injury, hypertension. hypertensive crisis, pulmonary hypertension) & Mortality
Time frame: 90 days
Number of occurrences
Symptomatic intracranial hemorrhage
Time frame: 90 days
Incidence of symptomatic intracranial hemorrhage, number of occurrences
Major Bleeding incidences
Time frame: 90 days
Number of occurrences
Adverse Events
Time frame: 90 days
Presence or absence
Bleeding requiring surgical intervention
Time frame: 90 days
Number of occurrences
Bleeding requiring intravenous vasoactive drugs
Time frame: 90 days
Number of occurrences
Intracranial hemorrhage
Time frame: 90 days
Number of occurrences
Intraocular bleed compromising vision
Time frame: 90 days
Number of occurrences
Fatal bleeding
Time frame: 90 days
Number of occurrences
AESI, Blood pressure
Time frame: 90 days
Number of events of systolic blood pressure [SBP] >220 mmHg or diastolic blood pressure [DBP] >120 mmHg
AESI, Liver panel
Time frame: 90 days
Number of events of Liver enzymes elevation >3.0 × Baseline or upper limit of normal [ULN]
AESI, neurological deterioration
Time frame: 90 days
Number of occurrences of Neurological deterioration (≥4-point increase from Baseline in National Institutes of Health Stroke Scale (NIHSS).
6 secondary outcomes
Clinical Activity, ASITN collateral score
Time frame: 90 days
Clinical Activity
Time frame: 90 days
Clinical Activity, NIHSS and mRS
Time frame: 90 days
Plasma Concentration of PP007
Time frame: 24 hours
Clinical Activity, eTICI
Time frame: 90 days
Clinical Activity, infarct growth
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- Derived from this study: PubMed 41585378Linfante 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.
Related trials for Acute Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsten Gruis, MD study director
Prolong Pharmaceuticals, LLC
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PP-007 (Two doses administered 24±6 hours apart) + SOC (IVT or MT or IVT+MT) in people with Acute Ischemic Stroke, run by Prolong Pharmaceuticals at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 51 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vital Signs (time frame: 90 days). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04677777, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025; AzTrials last refreshed its copy on 7 Nov 2026.