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OpenTrials
Completed

NCT Number: NCT04091945

A Study to Evaluate the Safety and Potential Efficacy of LT3001 Drug Product in Subjects With AIS

This is a multicenter, double-blind, single-dose, randomized, and placebo-controlled prospective Phase IIa clinical study, designed to evaluate LT3001 drug product versus placebo/control in subjects with AIS.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City, Taiwan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 to 90 years
  • NIHSS of 4 to 30
  • Diagnosis of AIS within 24 hours after stroke symptoms onset

Exclusion criteria

  • Treatement with approved drug during the current AIS
  • Pre-stroke disability
  • Imaging evidence of acute intracranial hemorrhage, intraparenchymal tumor, arteriovenous malformations, other central nervous system lesions that could increase bleeding risk, or aneurysm requiring treatment
  • Suspected subarachnoid hemorrhage
  • Seizure
  • Uncontrolled hypertension
  • INR >1.7 and/or abnormal aPTT or platelet count <100,000/mm3
  • Blood glucose concentration <50 mg/dL or >400 mg/dL
  • Lactating or pregnant subjects or those planning to become pregnant during the study
  • Received anticoagulants and/or antiplatelet therapy and glycoprotein IIb/IIIa inhibitors within 48 hours
  • AIS, myocardial infarction, serious head trauma or major surgery within 90 days
  • Bleeding event within 21 days
  • Puncture of noncompressible vessels within 7 days
  • Severe hepatic, renal, and/or infectious disease

Treatment and study plan

LT3001 Drug Product

Drug

Active comparator

Placebo

Drug

Placebo comparator

Primary outcomes

  1. The Percentage of Subject Have Symptomatic Intracranial Hemorrhage (sICH) of a Single Dose LT3001 Drug Product in Subjects With AIS.

    Time frame: Within 36 hours

    Compare the the percentage of subject having sICH between LT3001 drug product and Placebo.

Sponsors and collaborators

Lead sponsor

Lumosa Therapeutics Co., Ltd.

Industry

Registry information

Official study title

A Phase IIa, Double-Blind, Single Dose, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Potential Efficacy of LT3001 Drug Product in Subjects With Acute Ischemic Stroke (AIS)

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 17, 2019
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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