Acute Ischemic StrokePhase 1NEXISNCT07813130
A Phase 1b Study to Assess the Safety and Tolerability of AB126 Neural Exosomes in Patients With Moderate to Severe Acute Ischemic Stroke
A Phase 1 study testing AB126 Neural Exosomes Intravenous Injection in people with Acute Ischemic Stroke, run by Aruna Bio, Inc. at 3 sites in United States.
Trial summary
The goal of this clinical trial is to learn if AB126, an investigational treatment made from neural exosomes, is safe and well tolerated when given to adults with moderate to severe acute ischemic stroke (AIS) who have undergone endovascular thrombectomy (EVT) but have had limited neurological improvement after the… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- AB126 Neural Exosomes Intravenous Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2026to Apr 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients 18 to 85 years of age, inclusive.
- Provision of written informed consent obtained from participant or an acceptable legally authorized representative.
- Pre-stroke modified Rankin Scale score of 0 or 1.
- Diagnosis of AIS due to large vessel occlusion in the anterior circulation, confirmed by neuroimaging (NCCT, CTA).
- Diagnosis of moderate to severe cerebral ischemic stroke, defined by the presence of a measurable motor and/or speech-language deficit at pre-randomization, as assessed by the Investigator.
- Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥12 prior to EVT to ensure sufficient stroke severity.
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- Baseline imaging characteristics predictive of poor prognosis post-EVT defined by ASPECTS between 3 and 7 on NCCT.
- Has undergone EVT, specifically mechanical thrombectomy, for the treatment of the current AIS.
- Post-EVT NIHSS score, performed within 4 hours of EVT completion, must be between 12 and 25, inclusive, prior to randomization.
- Participants must demonstrate a change in NIHSS score of no more than ±30% from Baseline (pre-EVT) to Pre-Randomization (post-EVT).
- Patient must be capable of undergoing Magnetic Resonance Imaging (MRI).
- If male, participant must agree to use adequate contraceptive methods. If female, participant must be of non-childbearing potential or, if of childbearing potential, must agree to use adequate contraceptive methods.
- Patient must agree not to donate whole blood, blood components (including plasma and leukocytes), tissue, breast milk, ova, and sperm for one year following final administration of study drug.
Who cannot join
- Known sensitivity to bovine serum albumin or other components likely to be present in AB126;
- Posterior circulation stroke, including infarcts involving brainstem or cerebellum;
- Pre-existing significant neurological deficits that would confound outcome assessments, including:
- A pre-stroke modified Rankin Scale (mRS) score greater than 1
- A history of prior stroke with persistent neurological deficits;
- Clinically significant hemorrhagic transformation post-EVT, including:
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- PH-2 classification intracerebral hemorrhage (≥30% of infarcted area with significant mass effect)
- sICH, as determined by the Investigator;
- A > ±30% change in NIHSS from Baseline to Pre-Randomization (i.e., 30% change in either direction)
- Comatose patients or those with severely reduced consciousness, defined as a score ≥2 on NIHSS Item 1a (Level of Consciousness) at the time of post-EVT assessment;
- Patients with uncontrolled systemic medical conditions that may confound assessments or increase risk, including but not limited to:
- Severe or unstable cardiovascular disease (e.g., recent myocardial infarction, uncontrolled arrhythmias)
- Severe hepatic or renal disfunction (e.g., ALT/AST >2x ULN, bilirubin >1.5x ULN, or eGFR ≤30mL/min/1.73m2);
- Current clinically significant infection, including sepsis, meningitis, or active central nervous system infection;
- Recent history of seizures at stroke onset or a diagnosis of epilepsy;
- Planned withdrawal of care or comfort measures only at the time of Screening;
- Known or suspected life expectancy less than 90 days due to non-stroke related comorbidities (e.g., advanced malignancy, end-stage organ failure);
- Clinically significant stroke or head trauma within the previous 3 months, or residual neurological deficits from prior events that, in the opinion of the Investigator, would interfere with the assessment of clinical outcomes in the current study;
- Severe hyperglycemia or hypoglycemia at Screening, defined as blood glucose levels <50 mg/dL or >350 mg/dL. Participant may be eligible if glucose levels are stabilized during hospitalization prior to randomization, as assessed by the Investigator.
- Women who are pregnant or nursing;
- Comorbidities that, in the judgment of the Investigator, would interfere with the ability to assess safety of the investigational product or the interpretation of study results. Such comorbidities may include, but are not limited to:
- Active hepatic disease
- Unstable angina or severe cardiovascular instability
- Ongoing systemic infection
- Allergy to human tissue
- Restrictive pulmonary disease
- Chronic lung infection
- Prior participation in a clinical interventional trial within the last 6 months;
- Weight of ≥ 220 lbs.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Memorial Hermann - Memorial City Medical Center
Houston, Texas, 77024
Dr. Savitz, Principal Investigator, (832) 325-7080, Sean.I.Savitz@uth.tmc.edu
Memorial Hermann-Texas Medical Center
Houston, Texas, 77030
Dr. Savitz, Principal Investigator, (832) 325-7080, Sean.I.Savitz@uth.tmc.edu
Memorial Hermann- Southwest Hospital
Houston, Texas, 77074
Dr. Savitz, Principal Investigator, (832) 325-7080, Sean.I.Savitz@uth.tmc.edu
About this study
Official title: A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Adaptive, Dose Escalation Study to Assess the Safety and Tolerability of AB126 Neural Exosomes Intravenous Injection in Patients With Moderate to Severe Acute Ischemic Stroke Following Endovascular Therapy and Limited Neurological Improvement
The goal of this clinical trial is to learn if AB126, an investigational treatment made from neural exosomes, is safe and well tolerated when given to adults with moderate to severe acute ischemic stroke (AIS) who have undergone endovascular thrombectomy (EVT) but have had limited neurological improvement after the procedure. The study will also evaluate different doses of AB126 to help determine the highest dose that can be given safely. The main questions it aims to answer are: 1. Is AB126 safe and well tolerated when given to participants with AIS following EVT? 2. What dose of AB126 can be given safely? 3. Does treatment with AB126 provide preliminary evidence of improved neurological recovery following stroke? Researchers will compare participants who receive AB126 with participants who receive placebo to evaluate the safety and tolerability of AB126 and to collect preliminary information about recovery following stroke. Participants will: 1. Be randomly assigned to receive either AB126 or placebo. Neither participants nor the study team will know which treatment is assigned. 2. Receive 3 intravenous (IV) doses of AB126 or placebo. The first dose will be given as soon as possible after EVT, but no later than 6 hours after blood flow has been restored. The second and third doses will be given approximately 24 and 48 hours after EVT. 3. Undergo medical examinations, laboratory tests, neurological assessments, and brain imaging during the study. 4. Remain under observation at a comprehensive stroke center until hospital discharge. 5. Complete follow-up assessments by telephone and in person for approximately 1 year after treatment, including assessments at approximately 10, 30, 90, 180, 270, and 360 days after treatment.
- Conditions
- Acute Ischemic Stroke
- Being tested
- AB126 Neural Exosomes Intravenous Injection, AB126 Placebo
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AB126 Neural Exosomes Intravenous InjectionBiological
Three (3) intravenous injections of the active ingredient will be administered on Day 0, 1, and 2 after stroke.
AB126 PlaceboOther
AB126 Placebo, comprised of non-active ingredients, will be administered on Day 0, 1, and 2 after stroke.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose | Experimental | 8.5E+09 particles/kg/injection Receives: Biological: AB126 Neural Exosomes Intravenous Injection |
| Medium Dose | Experimental | 2.7E+10 particles/kg/injection Receives: Biological: AB126 Neural Exosomes Intravenous Injection |
| High Dose | Experimental | 8.5E+10 particles/kg/injection Receives: Biological: AB126 Neural Exosomes Intravenous Injection |
| Placebo | Placebo comparator | AB126 formulation buffer Receives: Other: AB126 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent adverse events
The primary objective of this study is to evaluate the safety and tolerability of escalating doses of AB126 in patients with moderate to severe AIS who have undergone EVT and demonstrate limited neurological improvement post-procedure. The primary safety study endpoints will be assessed through Day 90. These study endpoints will also be assessed through Day 360 or end of study.
Measured: Through Day 90
Changes in physical and clinical examination findings
Measured: Through Day 90
Rates of death
Measured: Through Day 90
Recurrent stroke
Measured: Through Day 90
Symptomatic intracranial hemorrhage (sICH)
Measured: Through Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aruna Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07813130
- Sponsor's protocol ID
- CLI-SDY-001
- Other IDs
- AB126-01-001
- Acronym
- NEXIS
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Adaptive, Dose Escalation Study to Assess the Safety and Tolerability of AB126 Neural Exosomes Intravenous Injection in Patients With Moderate to Severe Acute Ischemic Stroke Following Endovascular Therapy and Limited Neurological Improvement
- ClinicalTrials.gov ID
- NCT07813130
- Acronym / sponsor ID
- NEXIS / CLI-SDY-001
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Aruna Bio, Inc.Industry (pharma, biotech, devices)
- Collaborators
- The University of Texas Health Science Center, Houston
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 10 Sep 2026 (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 goal of this clinical trial is to learn if AB126, an investigational treatment made from neural exosomes, is safe and well tolerated when given to adults with moderate to severe acute ischemic stroke (AIS) who have undergone endovascular thrombectomy (EVT) but have had limited neurological improvement after the procedure. The study will also evaluate different doses of AB126 to help determine the highest dose that can be given safely. The main questions it aims to answer are: 1. Is AB126 safe and well tolerated when given to participants with AIS following EVT? 2. What dose of AB126 can be given safely? 3. Does treatment with AB126 provide preliminary evidence of improved neurological recovery following stroke? Researchers will compare participants who receive AB126 with participants who receive placebo to evaluate the safety and tolerability of AB126 and to collect preliminary information about recovery following stroke. Participants will: 1. Be randomly assigned to receive either AB126 or placebo. Neither participants nor the study team will know which treatment is assigned. 2. Receive 3 intravenous (IV) doses of AB126 or placebo. The first dose will be given as soon as possible after EVT, but no later than 6 hours after blood flow has been restored. The second and third doses will be given approximately 24 and 48 hours after EVT. 3. Undergo medical examinations, laboratory tests, neurological assessments, and brain imaging during the study. 4. Remain under observation at a comprehensive stroke center until hospital discharge. 5. Complete follow-up assessments by telephone and in person for approximately 1 year after treatment, including assessments at approximately 10, 30, 90, 180, 270, and 360 days after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low Dose | Experimental | Biological: AB126 Neural Exosomes Intravenous Injection8.5E+09 particles/kg/injection |
| Medium Dose | Experimental | Biological: AB126 Neural Exosomes Intravenous Injection2.7E+10 particles/kg/injection |
| High Dose | Experimental | Biological: AB126 Neural Exosomes Intravenous Injection8.5E+10 particles/kg/injection |
| Placebo | Placebo comparator | Other: AB126 PlaceboAB126 formulation buffer |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male and female patients 18 to 85 years of age, inclusive.
- Provision of written informed consent obtained from participant or an acceptable legally authorized representative.
- Pre-stroke modified Rankin Scale score of 0 or 1.
- Diagnosis of AIS due to large vessel occlusion in the anterior circulation, confirmed by neuroimaging (NCCT, CTA).
- Diagnosis of moderate to severe cerebral ischemic stroke, defined by the presence of a measurable motor and/or speech-language deficit at pre-randomization, as assessed by the Investigator.
Key exclusion criteria (29 listed)
- Known sensitivity to bovine serum albumin or other components likely to be present in AB126;
- Posterior circulation stroke, including infarcts involving brainstem or cerebellum;
- Pre-existing significant neurological deficits that would confound outcome assessments, including:
- Clinically significant hemorrhagic transformation post-EVT, including:
- A > ±30% change in NIHSS from Baseline to Pre-Randomization (i.e., 30% change in either direction)
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 |
|---|---|---|
| AB126 Neural Exosomes Intravenous InjectionThree (3) intravenous injections of the active ingredient will be administered on Day 0, 1, and 2 after stroke. | Biological | High Dose, Low Dose, Medium Dose |
| AB126 PlaceboAB126 Placebo, comprised of non-active ingredients, will be administered on Day 0, 1, and 2 after stroke. | Other | Placebo |
Primary outcome
Treatment-emergent adverse events
Time frame: Through Day 90
The primary objective of this study is to evaluate the safety and tolerability of escalating doses of AB126 in patients with moderate to severe AIS who have undergone EVT and demonstrate limited neurological improvement post-procedure. The primary safety study endpoints will be assessed through Day 90. These study endpoints will also be assessed through Day 360 or end of study.
Changes in physical and clinical examination findings
Time frame: Through Day 90
Rates of death
Time frame: Through Day 90
Recurrent stroke
Time frame: Through Day 90
Symptomatic intracranial hemorrhage (sICH)
Time frame: Through Day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Yes
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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.
3 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 AB126 Neural Exosomes Intravenous Injection in people with Acute Ischemic Stroke, run by Aruna Bio, Inc. at 3 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 13 inclusion and 29 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: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Savitz, Principal Investigator ((832) 325-7080, Sean.I.Savitz@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-emergent adverse events (time frame: Through Day 90). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2026.