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Recruiting Phase 2 NCT05686642

Efficacy and Safety of LT3001 on Treating the Acute Ischemic Stroke

Trial Parameters

Condition Acute Ischemic Stroke
Sponsor Shanghai Pharmaceuticals Holding Co., Ltd
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 300
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2023-04-06
Completion 2025-12-10
Interventions
LT3001 Drug:high dosePlaceboLT3001 Drug:low dose

Brief Summary

This phase II clinical study is designed to evaluate the safety and efficacy of LT3001 in the treatment of acute ischemic stroke

Eligibility Criteria

Inclusion Criteria: 1. Subjects aged between 18 and 80 years at screening; 2. Clinical diagnosis of acute ischemic stroke that causes evaluable neurological impairment; 3.4 points ≤ NIHSS score ≤ 25 points at randomization; 4.Subjects who are able to receive the investigational drug within 24 hours after the onset of stroke; 5.Female subjects of childbearing potential or male subjects whose sexual partner are women of childbearing potential have no pregnancy plan and voluntarily take effective contraceptive measures during the study period and for 3 months after the last dose; 6.All subjects sign the informed consent form by themselves or their guardians after receiving complete study information. Exclusion Criteria: 1. Subjects have received or plan to receive endovascular treatment and/or intravenous thrombolytic therapy recommended by Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2018 during this onset period; 2. Presence of disturbances of consciousness at

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