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RecruitingNCT07890298Updated Oct 22, 2026

A Study to Evaluate the Intracranial Arterial Recanalization With Multiple Doses of LT3001 Drug Product in AIS Participant

A Phase 2 interventional study of LT3001 Drug Product in Acute Ischemic Stroke, sponsored by Lumosa Therapeutics Co., Ltd.. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years to 88 Years. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Lumosa Therapeutics Co., Ltd. · Phase 2, Interventional, and Basic science

Updated Oct 22, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 88 Years
Sex
All
01

Study summary

This is a phase II, open-label, single-arm, exploratory study to evaluate the intracranial arterial recanalization of multiple doses of LT3001 drug product in participant with acute ischemic stroke (AIS)

Read the detailed description

This is a multicenter, open-labeled, prospective Phase II clinical study, designed to evaluate the effect of the intracranial arterial recanalization in AIS participant receiving LT3001 drug product. The study is planned to take place in multiple sites. Subjects who participate in this trial should be treated with standard of care of AIS therapies when appropriate.

02

Conditions studied

  • Acute Ischemic Stroke

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03

In context

Ischemic Stroke

2,653 studies on the registry are indexed under Ischemic Stroke; 936 are open to participants now.

This study's planned enrollment of 10 is below the median of 120 across 1,799 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Lumosa Therapeutics Co., Ltd. is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 88 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Participant or participant's legal representative consents to participation by signing the informed consent form (ICF) after receiving full information about the study.
  2. Participant is aged 18 to 88 years, inclusive, at the time of Screening (Visit 1).
  3. Participant is not to be treated with intravenous thrombolytic (e.g., recombinant tissue-type plasminogen activator) treatment or endovascular thrombectomy (EVT)
  4. Participant has NIHSS of 6 to 23.
  5. Participant is able to receive the 1st IP within 24 hours after stroke symptoms onset.
  6. Participants who are women of childbearing potential (WOCBP), or men whose sexual partners are WOCBP, are able and willing to use at least 1 highly effective method of contraception during the study until 3 months after last dosing of IP. A female participant is considered to be a WOCBP after menarche and until she is in a postmenopausal state for 12 months or otherwise permanently sterile (for which acceptable methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy).

Neuroimaging Inclusion Criteria:

  1. Participant is willing and able to undergo brain computed tomography angiography (CTA) or magnetic resonance angiography (MRA).

    • No known history of severe contrast allergy, anaphylactoid reaction, or other clinical conditions that contraindicate contrast agent administration for CTA or MRA
    • Must not have MRI contraindications such as non-MRI-compatible pacemakers, cochlear implants, ferromagnetic implants/devices, claustrophobia, or other conditions preventing safe MRI scanning
  2. Participant is confirmed to have an acute intracranial arterial occlusion.

Exclusion criteria

Exclusion Criteria:

  1. Participant has a pre-stroke disability that requires help for activities of daily living (mRS >2).
  2. Participant has Alberta Stroke Program Early CT Score (ASPECTS) of \<5.
  3. Participant has AOL =3 at Screening (Visit 1).
  4. Participant has symptoms of suspected subarachnoid hemorrhage, even if CT is normal.
  5. Participant has imaging evidence of acute intracranial hemorrhage, intracranial tumor (except small meningioma), arteriovenous malformations, other central nervous system lesions that could increase the risk of bleeding, or aneurysm requiring treatment.
  6. Participant has significant mass effect with midline shift.
  7. Participant has pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluations, e.g., seizures at onset of the current AIS, dementia.
  8. Participant has current uncontrolled hypertension despite treatment: systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg before dosing at Screening (Visit 1).
  9. Participant has hemorrhagic diathesis, coagulation factor deficiency or recent oral anticoagulant therapy with International Normalized Ratio (INR) >1.7 or activated partial thromboplastin time (aPTT) >3 times of upper limit of normal range at Screening (Visit 1).
  10. Participant has received one of the new oral anticoagulants within 48 hours before the 1st IP administration, e.g., dabigatran, apixaban, rivaroxaban, and edoxaban, except for dabigatran-treated participant who has been given a reversal agent, idarucizumab, before the 1st IP administration.
  11. Participant has platelet count \<100,000/mm3 at Screening (Visit 1).
  12. Participant has blood glucose concentration \<50 mg/dL or >400 mg/dL at Screening (Visit 1).
  13. Participant has moderate or severe hepatic, renal, and/or active infectious disease at Screening (Visit 1) as judged by the investigator. Participant with confirmed COVID-19 or influenza infection can be enrolled at the Investigator's discretion.
  14. Participant is lactating, pregnant (pregnancy test required for all female participants of childbearing potential), or planning to become pregnant during the study.
  15. Participant has history of sICH, prior AIS, myocardial infarction, serious head trauma, or any major surgery within 90 days before Screening (Visit 1).
  16. Participant has had a bleeding event within 21 days before Screening (Visit 1), e.g., gastrointestinal hemorrhage.
  17. Participant has puncture of noncompressible vessels within 7 days before Screening (Visit 1).
  18. Participant has participated in another investigational study and received investigational product within 30 days before Screening (Visit 1) or 5 half-lives (whichever is longer).
  19. In the opinion of the Investigator, the participant has serious, advanced, or terminal illness that will prevent improvement or follow-up visits.
  20. In the opinion of the Investigator, the participant is not appropriate for the study for any other reason.
05

Study design

Phase
Phase 2
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    LT3001 Drug Product

    Administered by intravenous infusion

    Drug: LT3001 Drug Product

Interventions

06

What researchers measure

Primary outcomes

  1. The rate of successful recanalization at 24 hours after the 1st IP. Successful recanalization is defined as any improvement in Arterial Occlusive Lesion (AOL) score.

    After administer the 1st IP, successful recanalization at 24 hours will be assessed by AOL score and the rate of successful recanalization will be calculated. The Arterial Occlusive Lesion (AOL) score is a 4-point angiographic grading scale (scored 0 to 3) used to measure the degree of recanalization (restoration of blood flow through the blocked target artery) in patients with acute ischemic stroke. Successful recanalization is defined as any improvement in AOL score.

    Time frame: 24 hours

07

Study locations

1 of 1 sites recruiting
  • Taichung Medical University, Taichung
    Taichung, Taiwan
    Recruiting
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07890298
Lead sponsor
Lumosa Therapeutics Co., Ltd.
Responsible party
Sponsor
First posted
Oct 22, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Jun 2028 (estimated)
Last update
Oct 22, 2026

Study contacts

Claire Sun
Contact
claire_sun@lumosa.com.tw
+886-2-26557918

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: LT3001

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