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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Pharmaceuticals Holding Co., Ltd

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

Treatment groups

300 Participants
are divided into 3 treatment groups