NCT07241520

Phase III Clinical Trial of SHPL-49 Injection in the Treatment of Acute Ischemic Stroke

Phase III Clinical Trial to Evaluate the Efficacy and Safety of SHPL-49 Injection in the Treatment of Acute Ischemic Stroke（SAIL）- a Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Phase III Clinical Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,096 (estimated)
• Sponsor: Shanghai Hutchison Pharmaceuticals Limited · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to determine the efficacy and safety of SHPL-49 intravenous infusion in acute ischemic stroke patients.

Detailed description

The objective of this study is to determine the efficacy and safety of SHPL-49 intravenous infusion for 7 consecutive days in acute ischemic stroke patients within 8hours after onset. This study is a Phase III, multicenter, randomized, double-blind, placebo-controlled parallel design. Participants receive twice daily dosing for 7 consecutive days, or once on Day 1 and Day 8 and twice daily on Days 2 to 7, with each participant scheduled to receive 14 doses throughout the clinical trial. 1096 participants will be randomized 1:1 to SHPL-49 injection treated group and placebo group.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	SHPL-49 Injection	2 ampoules of SHPL-49 Injection in 100 mL 0.9% sodium chloride will be administered as a 30-minute intravenous infusion and applied twice daily for 7 days.
DRUG	Placebo Injection	2 ampoules of Placebo Injection in 100 mL 0.9% sodium chloride will be administered as a 30-minute intravenous infusion and applied twice daily for 7days.

Timeline

• Start date: 2025-12-08
• Primary completion: 2027-06-30
• Completion: 2027-11-30
• First posted: 2025-11-21
• Last updated: 2026-01-06

Locations

1 site across 1 country: China