NCT06202378

Safety and Efficacy of SHPL-49 Injection in Participants With Acute Ischemic Stroke

A Multicenter, Randomized, Double Blind, Placebo Controlled Phase II Clinical Study to Evaluate the Safety and Efficacy of SHPL-49 Injection in the Treatment of Acute Ischemic Stroke

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 270 (actual)
• 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 safety and efficacy of SHPL-49 intravenous infusion for 7 consecutive days in the treatment of acute ischemic stroke subjects.

Detailed description

Trial Objectives: The primary objective of this study is to determine the effectiveness of different doses of SHPL-49 intravenous infusion for 7 consecutive days in the treatment of acute ischemic stroke subjects within 8h after onset. The secondary objective is to determine the safety of different doses of SHPL-49 intravenous infusion for 7 consecutive days in the treatment of acute ischemic stroke subjects within 8h after onset. Trial Design: This study is a Phase II, multicenter, randomized, double Blind, placebo-Controlled design. Participants receive twice daily dosing for 7 consecutive days, or once on Days 1 and Day 8 and twice daily on Days 2 to Day 7, with each subject scheduled to receive 14 doses throughout the clinical trial. 270 Participants will be randomized 1:1:1 to SHPL-49 injection treated group (3 ampoules of SHPL-49 injections, Bis in die（BID）), SHPL-49 injection treated group (6 ampoules of SHPL-49 injections , BID) and placebo group (BID).

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	3 ampoules of SHPL-49 Injection	3 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	6 ampoules of SHPL-49 Injection	6 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	0.9% Sodium Chloride Injection	100 mL 0.9% sodium chloride will be administered as a 30-minute intravenous infusion and applied twice daily for 7 days.

Timeline

• Start date: 2023-12-29
• Primary completion: 2024-11-26
• Completion: 2024-12-16
• First posted: 2024-01-11
• Last updated: 2025-10-28

Locations

16 sites across 1 country: China

Regulatory

• FDA-regulated drug study