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Study on the Safety and Effectiveness of LT3001 for Patients with Acute Ischemic Stroke

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Acute Ischemic Stroke (AIS), a condition where blood flow to a part of the brain is blocked, leading to potential brain damage. The study will evaluate a treatment called LT3001 Drug Product, which is administered as a solution through an intravenous infusion. This means the medication is given directly into a vein. The trial will also use a placebo for comparison purposes.

The purpose of the study is to determine the safety of multiple doses of the LT3001 Drug Product in individuals who have experienced an Acute Ischemic Stroke. Participants will receive either the drug or a placebo, and their health will be monitored to assess any side effects or adverse reactions. The study is designed to be double-blind, meaning neither the participants nor the researchers know who is receiving the actual drug or the placebo, to ensure unbiased results.

Participants in the study will be monitored for a period of time after receiving the treatment to observe any potential side effects. The main focus will be on identifying any adverse events that may be related to the treatment within 90 days of the first administration. This trial aims to provide valuable information on the safety and potential benefits of the LT3001 Drug Product for those affected by Acute Ischemic Stroke.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Diagnosis and eligibility

    The patient must have been diagnosed with acute ischemic stroke (AIS).

    The patient should be between 18 and 80 years old.

    The patient must have a National Institutes of Health Stroke Scale (NIHSS) score between 4 and 25.

    The patient must be able to receive the first investigational product (IP) within 24 hours after the onset of stroke symptoms.

    The patient must have adequate kidney function, no history of severe allergic reactions to contrast agents, and be able to undergo a contrast brain perfusion with either MRI or CT.

  2. Step 2

    Randomization and treatment

    The patient will be randomly assigned to receive either the LT3001 drug product or a placebo.

    The treatment will be administered as an intravenous infusion.

    The study is double-blind, meaning neither the patient nor the researchers will know which treatment the patient is receiving.

  3. Step 3

    Treatment duration

    The patient will receive multiple doses of the assigned treatment.

    The duration and frequency of the doses will be determined by the study protocol.

  4. Step 4

    Monitoring and follow-up

    The patient will be monitored for any adverse events (AEs) that may be related to the investigational product.

    The primary endpoint is the proportion of patients experiencing AEs within 90 days after the first administration of the investigational product.

Who can join the trial?

5 criteria

  • The patient must have been diagnosed with Acute Ischemic Stroke (AIS), which is a type of stroke caused by a blockage in a blood vessel in the brain.
  • The patient must be between 18 and 80 years old at the time of the first screening visit.
  • The patient must have a score between 4 and 25 on the NIHSS, which is a scale used to measure the severity of a stroke.
  • The patient must be able to receive the first dose of the investigational product within 24 hours after the stroke symptoms started.
  • The patient must have adequate kidney function, no history of severe allergic reactions to contrast agents, and be able to undergo a brain scan using either MRI (Magnetic Resonance Imaging) or CT (Computed Tomography) with contrast, which helps to see the blood flow in the brain.

Who cannot join the trial?

8 criteria

  • Having a different type of stroke other than Acute Ischemic Stroke (AIS). AIS is a condition where blood flow to a part of the brain is blocked.
  • Being outside the specified age range for the study. The study may have specific age limits for participants.
  • Having certain medical conditions that the study does not allow. These conditions might interfere with the study or the safety of the participant.
  • Being pregnant or breastfeeding, as the study may not be safe for pregnant or breastfeeding individuals.
  • Having a history of allergic reactions to the study drug or similar drugs.
  • Participating in another clinical trial at the same time, which could affect the results of this study.
  • Having a severe medical condition that could make participation unsafe or affect the study results.
  • Being unable to follow the study procedures or instructions, which is important for the study's success.
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Investigated drugs

LT3001 is a medication being studied for its safety and effectiveness in people who have had an acute ischemic stroke. This type of stroke happens when a blood clot blocks a blood vessel in the brain, reducing blood flow and oxygen. The trial is testing multiple doses of LT3001 to see how well it works and if it is safe for patients to use.

What is already known about the treatment

LT3001 – This medication is administered intravenously and is currently being studied in clinical trials for its safety and effectiveness in treating acute ischemic stroke. It is not yet widely used in medical practice, as it is still under investigation. The main therapeutic indication for LT3001 is to help patients who have suffered an acute ischemic stroke. At the molecular level, LT3001 works by targeting specific pathways to reduce the damage caused by the stroke. It is classified pharmacologically as a neuroprotective agent.

Investigated diseases

Acute Ischemic Stroke – This condition occurs when a blood clot blocks or narrows an artery leading to the brain, resulting in reduced blood flow and oxygen to brain tissue. The lack of oxygen causes brain cells to begin dying within minutes. Symptoms can include sudden numbness or weakness, especially on one side of the body, confusion, trouble speaking, or difficulty understanding speech. Vision problems, dizziness, loss of balance, or severe headache may also occur. The progression of the disease can lead to significant neurological damage if blood flow is not restored quickly. Immediate medical attention is crucial to minimize brain damage and improve outcomes.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-502001-15-00Protocol codeLT3001-205Estimated enrolment200 patientsSponsorLumosa Therapeutics Co. Ltd.

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