New stroke drug aleeto enters human trials – could it limit brain damage?
NCT ID NCT06759753
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This Phase 2 trial tests whether the drug Aleeto can improve neurological function in people who have had a moderate to severe ischemic stroke. About 192 participants will receive either Aleeto or a placebo by IV within 72 hours of their stroke. The main goal is to see if Aleeto leads to better recovery scores on the NIH Stroke Scale at 14 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Aleeto (intravenous injection)
- What this could lead to
- If it works, this could point toward a new treatment to reduce brain damage and improve recovery after a moderate to severe stroke.
- What could go wrong
- This is an early Phase 2 trial with only 192 people, so results may not apply to all stroke patients. The drug may not show meaningful benefit over placebo, and side effects are still being studied.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 192 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Jan 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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30 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age between 30 and 80 years (30 ≤ age ≤ 80). 2. Diagnosis of acute ischemic stroke confirmed by CT or MRI, according to the "Key Points for Diagnosis of Major Cerebrovascular Diseases in China 2019." 3. Time from symptom onset ≤ 72 hours. 4. NIHSS score between 6 and 24, with a score of ≥ 1 on items 5 and 6 of the NIHSS. 5. Pre-stroke mRS (modified Rankin Scale) \< 2, indicating independent activities of daily living. 6. Signed informed consent. Exclusion Criteria: 1. Intracranial hemorrhagic diseases identified by head CT: cerebral hemorrhage, extradural hemorrhage, subarachnoid hemorrhage, intraventricular hemorrhage, etc. 2. Combined with other active and major neurological diseases (such as induced seizures, poor drug control of recurrent seizures, multiple sclerosis, intracranial tumors, etc.). 3. History of infectious diseases (HIV positive or positive test history, HCV antibody positive or positive test history, HBV surface antigen positive and/or serum HBV DNA positive or serum HBV DNA \> 2 × 10\^8 IU/ml). 4. Severe renal or hepatic insufficiency. (Severe hepatic insufficiency is defined as alanine aminotransferase (ALT) value\>3 times normal upper limit or Aspartate aminotransferase (AST)\>3 times normal upper limit; Severe renal insufficiency is defined as creatinine\>1.5 times normal upper limit or creatinine clearance \< 50 ml/min, or over stage 3 of chronic kidney disease), severe heart failure (New York Heart Association grades III - IV). 5. Resistant Hypertension, systolic pressure ≥220mmHg or diastolic pressure ≥120mmHg. 6. History of Hemostatic disorder, systemic bleeding, thrombocytopenia or neutropenia, drug-induced hematology or liver dysfunction, white blood cell count \<2×10\^9/L or platelet count \<100×10\^9/L. 7. History of severe anemia within the past 1 month (hemoglobin \< 90g/L). 8. Body Mass Index (BMI) \< 16kg/m2 or BMI\> 35kg/m2. 9. Severe organic diseases with expected survival time \<5 years, such as malignant tumor. 10. Women of child bearing potential, pregnant or breastfeeding. 11. Individual who have difficulty communicating verbally to the extent that they are unable to communicate, understand or follow instructions normally, and are unable to cooperate with treatment and evaluation. 12. Combined with alcohol and drug abuse history. 13. Known history of allergy to biological agents such as proteins and cell products. 14. History of intracranial or spinal surgery, major surgery, or severe physical trauma within the past 4 weeks. 15. Received any vaccinations within the past 28 days. 16. Use of other investigational drugs within 30 days or 5 drug half-lives. 17. Unable to complete follow-up due to geographical or other reasons. 18. The researchers believe that the patient is not suitable to participate in this study. 19. Participated in other clinical trials.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Tiantan Hospital
RECRUITINGBeijing, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can PET scans reveal hidden heart inflammation after a stroke?
- Can an implanted heart monitor catch hidden irregular heartbeats after stroke?
- China builds national watchdog for brain blood vessel devices
- Can tiny neural exosomes help the brain heal after a severe stroke?
- Can a new antibody boost recovery after severe stroke?
- After stroke, a balloon or a stent? trial tests which rescue opens blocked brain arteries better