Phase 2
N=88
A Study to Evaluate the Safety and Efficacy of Multiple Doses of LT3001 Drug Product in AIS Subjects
Acute Ischemic Stroke
Bottom Line
View on ClinicalTrials.gov: NCT05403866 ↗Enrolled (actual)
88
Serious AEs
19.5%
Results posted
Dec 2025
Primary outcome: Primary: The Proportion of Subjects With Adverse Events (AEs), Judged to be Probably or Definitely Related to the Investigational Product (IP), Within 90 Days After the First IP Administration. — 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LT3001 Drug Product (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lumosa Therapeutics Co., Ltd.
- Primary completion
- May 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Proportion of Subjects With Adverse Events (AEs), Judged to be Probably or Definitely Related to the Investigational Product (IP), Within 90 Days After the First IP Administration. |
0; 0 | — |
Summary
This is a phase II, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of multiple doses of LT3001 drug product in subjects with acute ischemic stroke (AIS)
Eligibility Criteria
Inclusion Criteria
- Subject is aged 18 to 90 years.
- Subject has an NIHSS of 6 to 25.
- Subject is able to receive the first IP within 24 hours after stroke symptoms onset.
Neuroimaging Inclusion Criteria:
- Subject is able to undergo a contrast brain perfusion with either MRI or computed tomography (CT).
- Subject has Target Mismatch Profile on MRI (perfusion is included) or CTP: ischemic core volume ≤70 mL, mismatch ratio ≥1.2 and mismatch volume ≥5 mL.
Exclusion Criteria
- Subject has been treated or intent to treat with endovascular thrombectomy and/or intravenous thrombolytic during the current AIS.
- Subject has a pre-stroke disability (mRS ≥2).
- Subject has large ischemic core volume >70 mL or ASPECTS ≤5.
- Subject has symptoms of suspected subarachnoid hemorrhage.
- Subject has imaging evidence of acute intracranial hemorrhage, intracranial tumor, arteriovenous malformations, other central nervous system lesions that could increase the risk of bleeding, or aneurysm requiring treatment.
- Subject has significant mass effect with midline shift.
- Subject has pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluations.
- Subject has current uncontrolled hypertension despite treatment.
- Subject has INR >1.7 or abnormal aPTT or platelet count 400 mg/dL.
- Subject has moderate or severe hepatic, renal, and/or active infectious disease.
- Subject is lactating, pregnant, or planning to become pregnant during the study.
- Subject has had history of sICH, prior AIS, myocardial infarction, or serious head trauma within 90 days before Screening.
- Subject has had any major surgery within 90 days before Screening.
- Subject has had a bleeding event within 21 days before Screening.
- Subject has puncture of noncompressible vessels within 7 days before Screening.
- Subject has participated in another investigational study and received IP within 30 days before Screening or 5 half-lives (whichever is longer).
- In the opinion of the Investigator, the subject is not appropriate for the study.
Data sourced from ClinicalTrials.gov (NCT05403866). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.