Phase II Study of QD202 Injection for Safety and Effectiveness in Adults With Acute Ischemic Stroke Receiving Thrombolysis Treatment

What this Trial Is About

Researchers are evaluating the safety, pharmacokinetics, and effectiveness of a drug called QD202 in adults with acute ischemic stroke who are receiving thrombolysis but not endovascular thrombectomy. This randomized, double-blinded, placebo-controlled phase II trial aims to better understand how QD202 works and is tolerated in this patient group. The study is sponsored by Shanghai QuietD Biotechnology Co., Ltd. and will include up to 120 male and female participants aged 18 to 85 years. Participants will be randomly assigned to one of three groups two experimental groups receiving different doses of QD202 100 mg on Day 1 followed by either 5 mg or 10 mg daily from Day 2 to Day 5 or a placebo group receiving a matching placebo daily for five days. The study drug or placebo is given as a 60-minute intravenous infusion after completion of thrombolysis. The trial includes a treatment period of five days and follow-up visits on Day 7 or discharge day, Day 30, and Day 90. During the study, participants will undergo assessments including stroke severity scales such as the National Institutes of Health Stroke Scale NIHSS, functional outcome measures like the modified Rankin Scale mRS and Barthel Index BI, and blood tests to monitor drug levels and safety. Safety and tolerance will be followed through Day 90. Participants will have multiple visits during this period for evaluations of their neurological status and overall health.

Efficacy and Safety of QD202 in Participants With Acute Ischemic Stroke Undergoing Thrombolysis Excluding Endovascular Thrombectomy