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RECRUITING
NCT07581210
PHASE2

Efficacy and Safety of QD202 in Participants With Acute Ischemic Stroke Undergoing Thrombolysis Excluding Endovascular Thrombectomy

Sponsor: Shanghai QuietD Biotechnology Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a randomized, double-blinded, placebo-controlled study investigating the safety and efficacy of QD202 injection in patients with acute ischemic stroke undergoing thrombolysis excluding endovascular thrombectomy. Up to 120 male and female patients with acute ischemic stroke undergoing thrombolysis excluding endovascular thrombectomy will be dosed with QD202 injection or placebo as a 60 minute intravenous infusion after completion of the thrombolysis procedure on Day 1-5 of the study period. Subjects will undergo interim procedures at Day 7 or the day of discharge, Day 30, and end-of-study procedures on Day 90.

Official title: A Multicentre, Randomized, Double-blinded, Placebo-controlled Phase II Clinical Trial to Evaluate the Safety, Pharmacokinetic Profile, and Efficacy of QD202 Injection in Patients With Acute Ischemic Stroke Undergoing Thrombolysis

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-10-14

Completion Date

2026-12

Last Updated

2026-05-12

Healthy Volunteers

No

Interventions

DRUG

QD202

QD202 is a 19 amino acid peptide that consists of a 8 amino acid active domain and an 11 amino acid domain that enables the peptide to cross the blood-brain barrier.

DRUG

Placebo

The placebo matches the investigational drug in appearance.

Locations (14)

Meizhou People's Hospital

Meizhou, Guangdong, China

Luoyang Central Hospital

Luoyang, Henan, China

Nanshi Hospital of Nanyang

Nanyang, Henan, China

Jilin Province People's Hospital

Changchun, Jilin, China

Meihe Hospital the First Hospital of Jilin University

Meihekou, Jilin, China

Benxi Central Hospital

Benxi, Liaoning, China

General Hospital of Fuxin Mining Industry Group of Liaoning Health Industry Group

Fuxin, Liaoning, China

Central Hospital Affiliated to Shenyang Medical College

Shengyang, Liaoning, China

General Hospital of Northern Theater Command

Shenyang, Liaoning, China

Linyi People's Hospital

Linyi, Shandong, China

Weifang People's Hospital

Weifang, Shandong, China

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Linfen Central Hospital

Linfen, Shanxi, China