NCT07396337

Study to Assess the Efficacy and Safety of QHRD106 Injection in Acute Ischemic Stroke.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase IIb Clinical Trial of QHRD106 Injection for the Treatment of Acute Ischemic Stroke

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: Changzhou Qianhong Bio-pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the efficacy and safety of QHRD106 injection in treating acute ischemic stroke.

Detailed description

This is a multicenter, randomized, double-blind, placebo-controlled, phase IIb clinical trial of QHRD106 injection for the treatment of acute ischemic stroke. The goal of this trial is to explore the efficacy and safety of different doses of QHRD106 injection in patients with acute ischemic stroke (AIS) who are unfit for reperfusion therapy within 24 hours of symptom onset.Participants will receive a low-dose QHRD106 injection (5600 IU), a middle-dose QHRD106 injection (8400 IU), a high-dose QHRD106 injection (12600 IU), or a placebo intravenously within 24 hours of stroke onset. They will be treated once every 7 days, with a total of 3 doses over the course of the study.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	QHRD106 Injection (Low-dose group)	Participants will receive QHRD106 injection (5600 IU) every 7 days with a total of 3 doses.
DRUG	QHRD106 Injection (Middle-dose group)	Participants will receive QHRD106 injection (8400 IU) every 7 days with a total of 3 doses.
DRUG	QHRD106 Injection (High-dose group)	Participants will receive QHRD106 injection (12600 IU) every 7 days with a total of 3 doses.
DRUG	Placebo	Participants will receive placebo every 7 days with a total of 3 doses.

Timeline

• Start date: 2026-01-19
• Primary completion: 2026-10-31
• Completion: 2026-12-31
• First posted: 2026-02-09
• Last updated: 2026-02-09

Locations

1 site across 1 country: China