A Study to Evaluate the Safety and Efficacy of Multiple Doses of LT3001 Drug Product in AIS Subjects

NCT05403866 | Completed Phase 2 Results FDA Drug

• 1 other identifier: LT3001-205
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• 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.

  There were no subjects in either treatment group who met the predefined criteria for the primary safety endpoint: the proportion of subjects with TEAEs judged to be probably or definitely related to the IP within 90 days after the first IP administration.

  within 90 days after the first IP administration

Study Arms (2)

LT3001 Drug Product

EXPERIMENTAL

Administered by intravenous infusion

Drug: LT3001 Drug Product

Placebo

PLACEBO COMPARATOR

Administered by intravenous infusion

Drug: Placebo

Interventions

LT3001 Drug Product DRUG

Administered by intravenous infusion

LT3001 Drug Product

Placebo DRUG

Administered by intravenous infusion

Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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 \<100,000/mm\^3.
• Subject has received conventional heparin or new oral anticoagulants within 48 hours before the first IP administration.
• Subject has blood glucose concentration \<50 mg/dL or \>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.

Sponsors & Collaborators

• Lumosa Therapeutics Co., Ltd.: lead

Study Sites (1)

Chattanooga Center for Neurologic Research

Chattanooga, Tennessee, 37403, United States

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Sabrina Yeh
• Organization: Lumosa Therapeutics Co., Ltd.

sabrina_yeh@lumosa.com.tw

+886 2 26557918

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 3, 2022
• Study Start: August 17, 2022
• Primary Completion: May 23, 2025
• Study Completion: May 23, 2025
• Last Updated: December 26, 2025
• Results First Posted: December 26, 2025

Record last verified: 2025-12

Locations

US (1)