Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New stroke drug aleeto enters human trials – could it limit brain damage?

NCT ID NCT06759753

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 192 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Jan 2026

An estimate. End dates often move.

Lead sponsor

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

30 to 80 years

Sex

Anyone

Healthy volunteers

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

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Acute ischemic stroke are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Beijing Tiantan Hospital

    RECRUITING

    Beijing, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.