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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
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.
The placebo matches the investigational drug in appearance.
Meizhou People's Hospital
Meizhou, Guangdong, China
RECRUITINGLuoyang Central Hospital
Luoyang, Henan, China
RECRUITINGNanshi Hospital of Nanyang
Nanyang, Henan, China
RECRUITINGJilin Province People's Hospital
Changchun, Jilin, China
RECRUITINGMeihe Hospital the First Hospital of Jilin University
Meihekou, Jilin, China
RECRUITINGBenxi Central Hospital
Benxi, Liaoning, China
RECRUITINGGeneral Hospital of Fuxin Mining Industry Group of Liaoning Health Industry Group
Fuxin, Liaoning, China
RECRUITINGCentral Hospital Affiliated to Shenyang Medical College
Shengyang, Liaoning, China
RECRUITINGGeneral Hospital of Northern Theater Command
Shenyang, Liaoning, China
RECRUITINGLinyi People's Hospital
Linyi, Shandong, China
RECRUITING...and 4 more locations
Safety and Tolerance
To evaluate the safety and tolerability of intravenous infusion of QD202 in patients with acute ischemic stroke undergoing thrombolysis. Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs); clinically significant changes from baseline in laboratory tests, 12-lead electrocardiograms, vital signs, etc.
Time frame: Through study completion, an average of 90 days
Modified Rankin Scale (mRS)
Proportion of subjects achieving independent functioning as defined as a score of 0-1 or 0-2 on the mRS at Day 30 and Day 90.
Time frame: Day 30 and 90
National Institutes of Health Stroke Scale (NIHSS)
Proportion of subjects achieving a good outcome as defined as a score of 0-1 on the NIHSS at Day 7 or day of discharge.
Time frame: Day 7 or day of discharge
National Institutes of Health Stroke Scale (NIHSS)
Proportion of subjects achieving a good outcome as defined as a decrease of 4 or more points from baseline on the NIHSS at Day 7 or day of discharge.
Time frame: Baseline up to Day 7 or day of discharge
National Institutes of Health Stroke Scale (NIHSS)
Change in NIHSS score from baseline to Day 7 or day of discharge, Day 30, and Day 90.
Time frame: Baseline up to Day 90
Barthel Index (BI)
Proportion of subjects with a Barthel Index (BI) score ≥ 95 at Day 30 and Day 90 of treatment.
Time frame: Day 30 and 90
The maximum plasma concentration (C[max])
The C\[max\] is the maximum observed plasma concentration and will be determined for QD202.
Time frame: Baseline up to Day 5
Time to reach the maximum plasma concentration (T[max])
Time to reach maximum observed plasma concentration (T\[max\]) of QD202.
Time frame: Baseline up to Day 5
Area under the plasma concentration-time curve from time zero to last time of quantifiable concentration (AUC[0-t])
Area under the concentration-time curve from time zero to last time of quantifiable concentration of QD202.
Time frame: Baseline up to Day 5
Terminal elimination half-life (t1/2)
Apparent terminal elimination half-life of QD202.
Time frame: Baseline up to Day 5
Drug Clearance (CL)
The efficiency of irreversible elimination of QD202 from the body, typically measured in volume per time.
Time frame: Baseline up to Day 5
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