Acute Ischemic StrokePhase 2NCT07739160
The Efficacy and Safety of HRS-4029 in Acute Ischemic Stroke Patients
A Phase 2 study testing HRS-4029 in people with Acute Ischemic Stroke, run by Beijing Suncadia Pharmaceuticals Co., Ltd at 1 site in China.
Trial summary
This trial will evaluate the efficacy and safety of HRS-4029 compared with placebo in participants with acute ischemic stroke (AIS). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- HRS-4029
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 340 participants
- Where
- 1 siteChina
- Study dates
- Oct 2026to Jul 2027
- Phase
- Phase 2
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fully understand and voluntarily participate in this trial, and sign the informed consent form (the informed consent form can be signed voluntarily by the participant or their legal representative).
- Stroke onset within 3 hours prior to screening, and expected to receive study drug administration within 3 hours after stroke onset.
- Clinical diagnosis of acute ischemic stroke (AIS).
- Modified Rankin Scale (mRS) score ≤1 prior to stroke onset.
- National Institutes of Health Stroke Scale (NIHSS) score of 6 to 25 at screening, and the sum of NIHSS score for the upper limb and the lower limb is greater than or equal to 2.
Who cannot join
- Intracranial hemorrhagic diseases, including but not limited to hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc..
- Severe impairment of consciousness: NIHSS Item 1a (Level of Consciousness) score ≥ 2.
- Concurrent other neurological/psychiatric disorders (e.g., Parkinsonism, epilepsy, severe cognitive impairment, severe depression, etc.) that render the patient uncooperative or unwilling to cooperate with physical examination, or that may affect the evaluation of outcomes.
- Persistent systolic blood pressure ≥ 200 mmHg and/or diastolic blood pressure ≥ 110 mmHg following active antihypertensive treatment.
- Severe hyperglycemia or hypoglycemia.
- Any of the following within 3 months prior to enrollment: acute ST-elevation myocardial infarction , and/or acute decompensated heart failure, and/or QTc > 520 ms, and/or hospitalization or unplanned coronary intervention due to acute coronary syndrome, myocardial infarction, or cardiac arrest; or New York Heart Association (NYHA) Class III/IV heart failure; or known ventricular tachycardia.
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- History of severe hepatic impairment.
- History of severe renal insufficiency.
- Advanced malignancy or currently undergoing antineoplastic treatment.
- Female participants who are pregnant or breastfeeding, or female participants with a positive pregnancy test result at screening.
- Participation in another interventional clinical trial involving an investigational drug or medical device (defined as having signed an informed consent form and received the investigational product/device) within 3 months prior to the screening visit.
- Terminal illness with an estimated life expectancy of less than 1 year.
- Any other condition that, in the opinion of the investigator, renders the participant inappropriate for study participation.
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
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Yongjun Wang, 010-59978538, yongjunwang111@aliyun.com
About this study
Official title: The Efficacy and Safety of HRS-4029 for the Treatment of Acute Ischemic Stroke: a Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Clinical Trial
This trial will evaluate the efficacy and safety of HRS-4029 compared with placebo in participants with acute ischemic stroke (AIS).
- Conditions
- Acute Ischemic Stroke
- Being tested
- HRS-4029, 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.
HRS-4029Drug
HRS-4029
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| HRS-4029 low dose | Experimental | Not described Receives: Drug: HRS-4029 |
| HRS-4029 medium dose | Experimental | Not described Receives: Drug: HRS-4029 |
| HRS-4029 high dose | Experimental | Not described Receives: Drug: HRS-4029 |
| 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.
The Proportion of Participants With Modified Rankin Scale (mRS) Score ≤ 2
The modified Rankin score (mRS) is a 6-point scale commonly used to assess disability due to stroke, with higher values indicating worse outcomes.
0 = No symptoms; 1 = No significant disability; 2 = Slight disability; 3 = Moderate disability; 4 = Moderately severe disability; 5 = Severe disability; 6 = Death.
Measured: Day 90
Secondary outcomes (5)
The Infarct Volume
Measured: 24 hours
The Proportion of Participants With Improvement of 4 or more points, or return to the National Institutes of Health Stroke Scale (NIHSS) total score of 0 or 1
The National Institutes of Health Stroke Score (NIHSS) is a 15-item scale that measures neurological deficit in acute stroke patients. Each item is ranked using a 3-, 4-, or 5-point scale, including allowances for items that cannot be scored due to the patient's condition, with higher scores indicating more severe deficit. Total scores range from 0-42, with higher scores indicating more severe deficits.
Measured: Day 10
The Proportion of Participants With Modified Rankin Scale (mRS) score ≤ 1
Measured: Day 90
Ordinal Modified Rankin Scale (mRS) Score
Measured: Day 90
The Proportion of Participants With a Barthel Index (BI) Score ≥ 95
The Barthel Index (BI) is a 10-item ordinal scale used to measure performance in activities of daily living (ADL) and mobility. The BI scoring range is from 0-100, with lower scores representing greater dependency.
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionJul 2027 (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
- Model description
- HRS-4029 compared with placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Suncadia Pharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07739160
- Sponsor's protocol ID
- HRS-4029-201
- Status last verified
- Sep 2026
- First submitted
- 28 Jul 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided