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

NCT07396337 | Recruiting Phase 2 DMC

• 1 other identifier: PR-QHRD-106-ⅡB
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• modified rankin scale (mRS) score ≤ 1

  Day 90 after randomization

Secondary Outcomes (5)

• The modified Rankin Scale (mRS) scores at 90 days after stroke

  90 days after stroke onset

• The proportion of participants with a modified Rankin Scale (mRS) score of 0-2 at 30、90 days after stroke onset

  30、90 days after stroke onset

• The proportion of participants with a modified Rankin Scale (mRS) score of 0-1 at 30 days after stroke onset

  30 days after stroke onset

• The change of the National Institutes of Health Stroke Scale (NIHSS) score from baseline at 14 days after stroke onset

  Baseline, 14 days after stroke onset

• The proportion of Barthel Index (BI) scores ≥95 at 30 days and 90 days after stroke onset

  30 days and 90 days after stroke onset

Other Outcomes (3)

• Incidence of adverse events (AE)

  From the time of administration to day 90

• Incidence of serious adverse events (SAE)

  From the time of administration to day 90

• All-cause mortality

  From the time of administration to day 90

Study Arms (4)

QHRD106 injection（Low-dose group）

EXPERIMENTAL

Drug: QHRD106 Injection (Low-dose group)

QHRD106 injection（Middle-dose group）

EXPERIMENTAL

Drug: QHRD106 Injection (Middle-dose group)

QHRD106 injection（High-dose group）

EXPERIMENTAL

Drug: QHRD106 Injection (High-dose group)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

QHRD106 Injection (Low-dose group) DRUG

Participants will receive QHRD106 injection (5600 IU) every 7 days with a total of 3 doses.

QHRD106 injection（Low-dose group）

QHRD106 Injection (Middle-dose group) DRUG

Participants will receive QHRD106 injection (8400 IU) every 7 days with a total of 3 doses.

QHRD106 injection（Middle-dose group）

QHRD106 Injection (High-dose group) DRUG

Participants will receive QHRD106 injection (12600 IU) every 7 days with a total of 3 doses.

QHRD106 injection（High-dose group）

Placebo DRUG

Participants will receive placebo every 7 days with a total of 3 doses.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old and ≤ 80 years old;
• Patients diagnosed as acute ischemic stroke according to the latest guidelines；
• Patients who have not received or have no plan to receive standard intravenous thrombolysis within 24 hours after the onset of the disease and can complete the first administration of the investigational drug within 24 hours after the onset.；
• Total National Institute of Health stroke scale (NIHSS)≥6 and ≤20, and the sum of NIHSS score for the upper limb and the lower limb is greater than or equal to 2；
• The mRS score before the onset of the disease is ≤ 1 point;
• Obtain the informed consent form signed by the patient or their guardian.

You may not qualify if:

• Combine intracranial hemorrhagic diseases, including hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc；
• Individuals with any of the following allergy histories must be excluded: 1) Those who are allergic to the test drug or similar components; 2) Those who are allergic to the materials used in imaging examinations; 3) Those who are allergic to any drugs, medical devices, or products derived from pigs or other mammals (such as porcine insulin, etc.); 4) Those who have had severe allergic reactions (such as anaphylactic shock, angioedema) or have a clear history of allergy to two or more different chemical structures of drugs；
• Known to have alpha-1 antitrypsin deficiency;
• Severe cognitive impairment: Patients with a score of ≥ 2 on the NIHSS scale for the 1a level of consciousness;
• Brain CT or MRI indicating large-scale anterior circulation cerebral infarction (the infarction area exceeding one-third of the territory supplied by the middle cerebral artery);
• Stroke with rapid improvement of symptoms after informed consent, or suspected acute ischemic symptoms caused by other reasons;
• Those preparing for or having undergone endovascular treatment;
• Since the onset of this illness, the following drugs with neuroprotective effects have been administered: commercially available edaravone, edaravone-berclor, butylphthalide, human urokinase (Ureklin), pancreatic kallikrein, citicoline, nimodipine, ganglioside, apomorphine, brain glycoprotein, fasudil, compound brain peptide ganglioside, piracetam, oralacetam, cattle serum albumin injection, cattle serum protein extract injection, ginkgo biloba lactone injection, ginkgo diterpene gluconate injection, glutaric acid injection, blood clotting soft capsules, and injections containing any one or more of the following Chinese herbal ingredients: Ligusticum chuanxiong, Salvia miltiorrhiza, Rhodiola rosea extracts；
• Severe hypertension: After using antihypertensive drugs before random administration, the systolic blood pressure remained ≥ 185 mmHg or the diastolic blood pressure remained ≥ 110 mmHg;
• Within the 7 days prior to screening, any angiotensin-converting enzyme inhibitor (ACEI: captopril, lisinopril, etc.) was used;
• During the trial, the plan is to use angiotensin-converting enzyme inhibitors (ACEI: captopril, lisinopril, etc.)；
• Cases where systolic blood pressure (SBP) was less than 100 mmHg or mean arterial pressure (MAP) was less than 65 mmHg occurred before random grouping after the onset of stroke symptoms; Note: MAP = DBP + \[1/3 (SBP - DBP)\] (measured using an non-invasive blood pressure cuff device);
• Patients with active severe infections who require systemic anti-infective treatment;
• Severe renal dysfunction: Serum creatinine \> 2 times the upper limit of normal value or creatinine clearance rate \< 30 mL/min (Cockcroft-Gault formula), or known renal failure, uremia and other severe renal dysfunction diseases; (Note: Cockcroft-Gault formula: ① For males: CLcr (mL/min) = \[140 - Age (years)\] × Weight (kg) / \[0.814 × Serum creatinine (μmol/L)\]; ② For females: CLcr (mL/min) = { \[140 - Age (years)\] × Weight (kg) / \[0.814 × Serum creatinine (μmol/L)\] } × 0.85)；
• Severe liver dysfunction: ALT or AST is more than 3 times the upper limit of the normal range, or other known liver diseases such as liver failure, cirrhosis, portal hypertension (esophageal varices), active hepatitis, etc.;

Sponsors & Collaborators

• Changzhou Qianhong Bio-pharma Co., Ltd.: lead

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Yun Xu, professor

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yun Xu, professor

CONTACT

13914764479; xuyun20042001@aliyun.com

Study Design

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

Study Record Dates

• First Submitted: February 1, 2026
• First Posted: February 9, 2026
• Study Start: January 19, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)