Acute Ischemic StrokePhase 2NCT07396337
Study to Assess the Efficacy and Safety of QHRD106 Injection in Acute Ischemic Stroke.
A Phase 2 study testing QHRD106 Injection (Low-dose group), QHRD106 Injection (Middle-dose group) and QHRD106 Injection (High-dose group) in people with Acute Ischemic Stroke, run by Changzhou Qianhong Bio-pharma Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to determine the efficacy and safety of QHRD106 injection in treating acute ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- QHRD106 Injection (Low-dose group), QHRD106 Injection (Middle-dose group) and QHRD106 Injection (High-dose group)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- 19 Jan 2026to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.;
- Patients with a heart function rating of grade II or above (according to the New York Heart Association (NYHA) heart function classification) or those with a history of congestive heart failure;
- Patients with concurrent malignant tumors or those undergoing anti-tumor treatment;
- Pregnant women, lactating women, or those planning to become pregnant;
- Those who have a history of epilepsy or experienced epileptic-like symptoms during a stroke, or those with severe mental disorders, mental impairments, intellectual disabilities or dementia;
- Those suspected or confirmed to have alcohol dependence, or who consumed more than 3 units of alcohol (for men) or 2 units (for women) within 24 hours before the onset of the disease (1 unit = 360 mL of beer or 45 mL of 40% alcohol liquor or 150 mL of wine);
- Those who have participated in other drug or non-drug clinical studies within 3 months prior to signing the informed consent form, or are currently involved in other clinical studies;
- Those with severe systemic diseases and an expected survival period of less than 90 days;
- Those who cannot tolerate venipuncture or experience dizziness or fainting when standing up, or those who are unwilling to receive multiple intramuscular injections for administration;
- Patients considered by the researchers to be unsuitable for participating in this clinical study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
Yun Xu, professor, 13914764479, xuyun20042001@aliyun.com
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase IIb Clinical Trial of QHRD106 Injection for the Treatment of Acute Ischemic Stroke
The purpose of this study is to determine the efficacy and safety of QHRD106 injection in treating acute ischemic stroke.
Read the 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
- Being tested
- QHRD106 Injection (Low-dose group), QHRD106 Injection (Middle-dose group), QHRD106 Injection (High-dose group), Placebo
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QHRD106 Injection (Low-dose group)Drug
Participants will receive QHRD106 injection (5600 IU) every 7 days with a total of 3 doses.
QHRD106 Injection (Middle-dose group)Drug
Participants will receive QHRD106 injection (8400 IU) every 7 days with a total of 3 doses.
QHRD106 Injection (High-dose group)Drug
Participants will receive QHRD106 injection (12600 IU) every 7 days with a total of 3 doses.
PlaceboDrug
Participants will receive placebo every 7 days with a total of 3 doses.
| Study group | Role | What they receive |
|---|---|---|
| QHRD106 injection（Low-dose group） | Experimental | Not described Receives: Drug: QHRD106 Injection (Low-dose group) |
| QHRD106 injection（Middle-dose group） | Experimental | Not described Receives: Drug: QHRD106 Injection (Middle-dose group) |
| QHRD106 injection（High-dose group） | Experimental | Not described Receives: Drug: QHRD106 Injection (High-dose group) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified rankin scale (mRS) score ≤ 1
Measured: Day 90 after randomization
Secondary outcomes (5)
The modified Rankin Scale (mRS) scores at 90 days after stroke
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, 14 days after stroke onset
The proportion of Barthel Index (BI) scores ≥95 at 30 days and 90 days after stroke onset
Measured: 30 days and 90 days after stroke onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start19 Jan 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changzhou Qianhong Bio-pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yun Xu, professor, Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07396337
- Sponsor's protocol ID
- PR-QHRD-106-ⅡB
- Status last verified
- Feb 2026
- First submitted
- 1 Feb 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase IIb Clinical Trial of QHRD106 Injection for the Treatment of Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT07396337
- Acronym / sponsor ID
- PR-QHRD-106-ⅡB
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Changzhou Qianhong Bio-pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Jan 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (24 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QHRD106 Injection (Low-dose group)Participants will receive QHRD106 injection (5600 IU) every 7 days with a total of 3 doses. | Drug | QHRD106 injection（Low-dose group） |
| QHRD106 Injection (Middle-dose group)Participants will receive QHRD106 injection (8400 IU) every 7 days with a total of 3 doses. | Drug | QHRD106 injection（Middle-dose group） |
| QHRD106 Injection (High-dose group)Participants will receive QHRD106 injection (12600 IU) every 7 days with a total of 3 doses. | Drug | QHRD106 injection（High-dose group） |
| PlaceboParticipants will receive placebo every 7 days with a total of 3 doses. | Drug | Placebo |
Primary outcome
modified rankin scale (mRS) score ≤ 1
Time frame: Day 90 after randomization
5 secondary outcomes
The modified Rankin Scale (mRS) scores at 90 days after stroke
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, 14 days after stroke onset
The proportion of Barthel Index (BI) scores ≥95 at 30 days and 90 days after stroke onset
Time frame: 30 days and 90 days after stroke onset
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yun Xu, professor principal investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QHRD106 Injection (Low-dose group), QHRD106 Injection (Middle-dose group) and QHRD106 Injection (High-dose group) in people with Acute Ischemic Stroke, run by Changzhou Qianhong Bio-pharma Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yun Xu, professor (13914764479, xuyun20042001@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified rankin scale (mRS) score ≤ 1 (time frame: Day 90 after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.