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RECRUITING
NCT07241520
PHASE3

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

Sponsor: Shanghai Hutchison Pharmaceuticals Limited

View on ClinicalTrials.gov

Summary

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

1096

Start Date

2025-12-08

Completion Date

2027-11-30

Last Updated

2026-01-06

Healthy Volunteers

No

Interventions

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.

Locations (1)

Linfen Central Hospital

Linfen, Shanxi, China