The Efficacy and Safety of HRS-4029 in Acute Ischemic Stroke Patients

NCT07739160 | Not Yet Recruiting Phase 2

• 1 other identifier: HRS-4029-201
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• The Proportion of Participants With Modified Rankin Scale (mRS) Score ≤ 2

  The 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.

  Day 90

Secondary Outcomes (5)

• The Infarct Volume

  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

  Day 10

• The Proportion of Participants With Modified Rankin Scale (mRS) score ≤ 1

  Day 90

• Ordinal Modified Rankin Scale (mRS) Score

  Day 90

• The Proportion of Participants With a Barthel Index (BI) Score ≥ 95

  Day 90

Study Arms (4)

HRS-4029 low dose

EXPERIMENTAL

Drug: HRS-4029

HRS-4029 medium dose

EXPERIMENTAL

Drug: HRS-4029

HRS-4029 high dose

EXPERIMENTAL

Drug: HRS-4029

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

HRS-4029 DRUG

HRS-4029

HRS-4029 high dose; HRS-4029 low dose; HRS-4029 medium dose

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Beijing Suncadia Pharmaceuticals Co., Ltd: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Jiawen Xu

CONTACT

+86 19921874134; jiawen.xu.jx130@hengrui.com

Xiao Chen

CONTACT

+86 18861359350; xiao.chen.xc1@hengrui.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

Model Details: HRS-4029 compared with placebo

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: July 31, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07

Locations

CN (1)