Phase 1b Study of Anisodine Hydrobromide for Safety and Dose Finding in Adults With Acute Ischemic Stroke Undergoing Endovascular Therapy

What this Trial Is About

Researchers are conducting a Phase 1b clinical trial to study anisodine hydrobromide in patients who have acute ischemic stroke and are undergoing endovascular therapy. The main goals are to assess the safety and tolerability of the drug and to find the appropriate dose for future studies. This open-label, non-randomized trial uses a dose-escalation design to identify the maximum tolerated dose and recommended dose for Phase II trials. Participants receive anisodine hydrobromide intravenously at one of four dose levels 1.0 mg, 1.5 mg, 2.0 mg, or 2.5 mg twice daily for seven consecutive days alongside standard endovascular therapy. The first dose is given before vascular recanalization but must not delay the endovascular procedure. The drug is diluted in sodium chloride solution and infused over about 60 minutes. All participants also receive standard care for stroke, including mechanical thrombectomy and other procedures as needed. Throughout the study, participants are closely monitored for safety and neurological outcomes. Researchers will measure safety events within eight days of the first dose, neurological changes within 24 hours, stroke infarct volume at day 8, and functional recovery at day 90 using the modified Rankin Scale. Additional assessments include brain hemorrhage events and all-cause mortality within 90 days. The total participation duration extends to approximately three months to capture these outcomes and ensure safety monitoring.

Anisodine Hydrobromide for Patients With Acute Ischemic Stroke Undergoing Endovascular Therapy (HEAL)