A Phase II Clinical Study of LT3001 for Injection in the Treatment of Acute Ischemic Stroke

Inclusion criteria

• Clinical diagnosis of acute ischemic stroke that causes evaluable neurological impairment;
• 6 points ≤ NIHSS score ≤ 25 points at randomization;
• Participants who are able to receive the investigational drug within 24 hours after the onset of stroke;
• Female Participants of childbearing potential or male Participants 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;
• All participants sign the informed consent form by themselves or their guardians after receiving complete study information.

Exclusion criteria

• Participants have received or plan to receive endovascular treatment and/or intravenous thrombolytic therapyduring this onset period;
• Presence of disturbances of consciousness at screening and NIHSS 1a ≥ 2 points;
• Neurological signs have improved rapidly and spontaneously at screening;
• Participants who have used or are using protocol-prohibited medications after the onset;
• Participants with pre-stroke disability;
• Imaging evidence of intracranial hemorrhagic diseases, intraparenchymal brain tumor, arteriovenous malformation, aortic arch dissection, other central nervous system lesions that may increase the risk of hemorrhage, or arterial aneurysm requiring treatment;
• Massive infarction on imaging;
• Participants who are unable to cooperate due to epileptic seizure at the onset of stroke or other concomitant mental disorders or are unwilling to cooperate;
• Participants previously diagnosed with concurrent malignant tumors who are currently undergoing anti-tumor treatment or have an expected survival of less than 3 months；
• Systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 100 mmHg after active antihypertensive therapy;
• Acute hemorrhage tendency;
• Blood glucose level < 50 mg/dL or > 400 mg/dL;
• Active visceral hemorrhage;
• Lactating or pregnant Participants, or women of childbearing potential with positive pregnancy test results;
• International normalized ratio > 1.7 or prothrombin time > 15 s;
• Participants with a history of serious hypersensitivity;
• Participants who experienced AIS, ICH, acute myocardial infarction or serious head trauma before screening;
• Participants who underwent any major surgery before screening;
• Participants with a history of active digestive ulcer before screening;
• Participants who experienced hemorrhagic disease before screening;
• Participants who underwent arterial puncture at the site not easy for hemostasis by compression before screening;
• Presence of active hepatitis, cirrhosis, or severe renal insufficiency;
• Participants who have participated in another investigational study and used investigational product before screening;
• Other conditions unsuitable for participation in this study determined by the Investigator.