About this trial
This phase II clinical study is designed to evaluate the efficacy and safety of LT3001 in the treatment of acute ischemic stroke
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- LT3001 Drug:high dose
- LT3001 Drug: low dose
- Placebo