NCT07581210

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
7mo left

Started Oct 2025

Shorter than P25 for phase_2

Geographic Reach
1 country

14 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Oct 2025Dec 2026

Study Start

First participant enrolled

October 14, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 12, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

May 12, 2026

Status Verified

May 1, 2026

Enrollment Period

10 months

First QC Date

April 30, 2026

Last Update Submit

May 6, 2026

Conditions

Acute Ischemic Stroke

Keywords

Neuroprotective AgentThrombolysis

Outcome Measures

Primary Outcomes (1)

  • 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.

    Through study completion, an average of 90 days

Secondary Outcomes (10)

  • Modified Rankin Scale (mRS)

    Day 30 and 90

  • National Institutes of Health Stroke Scale (NIHSS)

    Day 7 or day of discharge

  • National Institutes of Health Stroke Scale (NIHSS)

    Baseline up to Day 7 or day of discharge

  • National Institutes of Health Stroke Scale (NIHSS)

    Baseline up to Day 90

  • Barthel Index (BI)

    Day 30 and 90

  • +5 more secondary outcomes

Other Outcomes (1)

  • Cerebral Infarct Volume

    Baseline up to Day 7 or day of discharge

Study Arms (3)

QD202, 5 milligram (mg)

EXPERIMENTAL

Participants will receive 100 mg of QD202 on Day 1 and 5 mg of QD202 daily from Day 2 to Day 5.

Drug: QD202

QD202, 10 milligram (mg)

EXPERIMENTAL

Participants will receive 100 mg of QD202 on Day 1 and 10 mg of QD202 daily from Day 2 to Day 5.

Drug: QD202

Placebo Comparator

PLACEBO COMPARATOR

Participants will receive matching placebo daily from Day 1 to Day 5.

Drug: Placebo

Interventions

QD202DRUG

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.

QD202, 10 milligram (mg)QD202, 5 milligram (mg)
PlaceboDRUG

The placebo matches the investigational drug in appearance.

Placebo Comparator

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Subjects aged 18-85 years (inclusive), regardless of gender;
  • \. Diagnosed with acute ischemic stroke according to the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke (2023);
  • \. Time from stroke onset ≤ 24 hours (Onset time is calculated from the time stroke symptoms appear. If the stroke occurred during sleep or if the time of symptom onset cannot be accurately determined due to aphasia, impaired consciousness, or other reasons, the time the subject was last known to be normal should be used as the onset time);
  • \. Pre-stroke modified Rankin Scale (mRS) score ≤ 1;
  • \. After this event and prior to thrombolysis, NIHSS score is between 6 and 20 (inclusive), and the sum of scores on NIHSS Item 5 (motor arm) and Item 6 (motor leg) is ≥ 2;
  • \. Planned for or have already undergone thrombolytic therapy;
  • \. Female subjects of childbearing potential must have a negative serum pregnancy test and report no sexual activity within 14 days prior to screening. Subjects of childbearing potential (female or male) must agree to have no plans for pregnancy or sperm donation throughout the study period and are willing to use at least one effective method of contraception;
  • \. The subject or their legal guardian voluntarily signs the informed consent form (ICF).

You may not qualify if:

  • \. Allergy to any component of QD202 or the placebo.
  • \. Transient ischemic attack (TIA).
  • \. Poorly controlled blood pressure despite active treatment (hypertension: systolic blood pressure ≥220 mmHg and/or diastolic blood pressure ≥120 mmHg; hypotension: systolic blood pressure ≤90 mmHg and/or diastolic blood pressure ≤40 mmHg).
  • \. Severe hyperglycemia/hypoglycemia: blood glucose ≥400 mg/dL (22.2 mmol/L) or ≤50 mg/dL (2.8 mmol/L).
  • \. Heart rate \<50 beats per minute and/or \>120 beats per minute; second- or third-degree atrioventricular block, sinoatrial block, or sinus arrest; history within 6 months prior to screening of heart failure (NYHA Class III or IV), unstable angina, acute myocardial infarction, or severe arrhythmia (including but not limited to rapid atrial fibrillation, atrial flutter, frequent premature beats, supraventricular or ventricular tachycardia).
  • \. Severe impairment of consciousness after the current event and prior to thrombolysis: NIHSS level of consciousness (item 1a) score ≥2.
  • \. History of severe psychiatric disorder or severe dementia.
  • \. History of depression or anxiety, if the investigator deems participation in this clinical trial inappropriate.
  • \. Subjects unsuitable for thrombolytic therapy, or those who have undergone or are planned to undergo endovascular interventional therapy.
  • \. Use of therapeutic neuroprotective agents after stroke onset, including commercially available edaravone, edaravone dexborneol injection concentrate and sublingual tablets, ginkgolides, ginkgo diterpene lactone meglumine, nimodipine, gangliosides, citicoline, piracetam, oxiracetam, butylphthalide, cinepazide maleate injection, mouse nerve growth factor, potential neuroprotective Cerebrolysin (cerebroprotein hydrolysate), deproteinized calf blood extractives injection, ulinastatin, etc. (except mannitol used to reduce intracranial pressure).
  • \. Concurrent malignancy diagnosed previously and currently undergoing anti-tumor therapy.
  • \. History of severe systemic disease with an estimated life expectancy of \<90 days.
  • \. Diagnosed with severe active liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis) or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.0 times the upper limit of normal (ULN).
  • \. Diagnosed with severe active kidney disease, renal insufficiency, or estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m².
  • \. Bleeding tendency, including platelet count (PLT) \<75.0×10⁹/L, or history of major bleeding within 3 months prior to the current event.
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Meizhou People's Hospital

Meizhou, Guangdong, China

RECRUITING

Luoyang Central Hospital

Luoyang, Henan, China

RECRUITING

Nanshi Hospital of Nanyang

Nanyang, Henan, China

RECRUITING

Jilin Province People's Hospital

Changchun, Jilin, China

RECRUITING

Meihe Hospital the First Hospital of Jilin University

Meihekou, Jilin, China

RECRUITING

Benxi Central Hospital

Benxi, Liaoning, China

RECRUITING

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

Fuxin, Liaoning, China

RECRUITING

Central Hospital Affiliated to Shenyang Medical College

Shengyang, Liaoning, China

RECRUITING

General Hospital of Northern Theater Command

Shenyang, Liaoning, China

RECRUITING

Linyi People's Hospital

Linyi, Shandong, China

RECRUITING

Weifang People's Hospital

Weifang, Shandong, China

RECRUITING

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Linfen Central Hospital

Linfen, Shanxi, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Yichuan Cai

CONTACT

86-13524815449caiyc@quietdbio.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2026

First Posted

May 12, 2026

Study Start

October 14, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

May 12, 2026

Record last verified: 2026-05

Locations

CN(14)