NCT07233070

Brief Summary

This study plans to enroll a total of 208 patients with Acute Ischemic Stroke (AIS) who present within 4.5 to 24 hours of symptom onset and meet the specified imaging criteria.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
208

participants targeted

Target at P75+ for phase_2

Timeline
8mo left

Started Oct 2025

Shorter than P25 for phase_2

Geographic Reach
1 country

2 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 Progress44%
Oct 2025Jan 2027

Study Start

First participant enrolled

October 31, 2025

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

November 20, 2025

Status Verified

October 1, 2025

Enrollment Period

11 months

First QC Date

November 14, 2025

Last Update Submit

November 18, 2025

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

  • mRS score of 0-1 at 90 days

    within 90 days after the start of administration

Secondary Outcomes (16)

  • Reperfusion rate at 24 hours;

    within 24 hours after the start of administration

  • Recanalization rate at 24 hours;

    within 24 hours after the start of administration

  • Proportion of subjects with ≥8-point reduction in NIHSS score or NIHSS score of 0-1 at 24 hours;

    within 24 hours after the start of administration

  • Infarct volume at 7 days;

    within 7 days after the start of administration

  • Proportion of subjects with ≥8-point reduction in NIHSS score or NIHSS score of 0-1 at 7 days;

    within 7 days after the start of administration

  • +11 more secondary outcomes

Study Arms (4)

Treatment group A: HRS-7450 Injection

EXPERIMENTAL
Drug: HRS-7450 Injection

Treatment group B: HRS-7450 Injection

EXPERIMENTAL
Drug: HRS-7450 Injection

Treatment group C: HRS-7450 Injection

EXPERIMENTAL
Drug: HRS-7450 Injection

Treatment group D: HRS-7450 Injection Placebo.

PLACEBO COMPARATOR
Drug: HRS-7450 Injection Placebo

Interventions

HRS-7450 InjectionDRUG

HRS-7450 Injection; low dose

Treatment group A: HRS-7450 Injection
HRS-7450 Injection PlaceboDRUG

HRS-7450 Injection Placebo

Treatment group D: HRS-7450 Injection Placebo.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fully understand and voluntarily participate in this study, and sign the informed consent form;
  • Aged between 18 and 80 years inclusive (18 ≤ age ≤ 80), regardless of gender;
  • Onset of symptoms within 4.5 to 24 hours;
  • Clinically diagnosed with acute ischemic stroke;
  • Pre-stroke modified Rankin Scale (mRS) score \< 2;
  • National Institutes of Health Stroke Scale (NIHSS) score between 6 and 25 (inclusive) at screening;
  • Female subjects of childbearing potential and male subjects with partners of childbearing potential must use highly effective contraception and avoid sperm/ova donation.

You may not qualify if:

  • Treatment with thrombolytic therapy.
  • Planned endovascular therapy.
  • Arterial dissection of the head, neck, or aorta.
  • Multiple infarctions across multiple large vascular territories.
  • NIHSS level of consciousness item 1a score \> 2.
  • Neurological deficits presenting after a seizure or post-ictal state, or the presence of other neurological conditions leading to uncooperative or unwillingness to cooperate with examination.
  • Hypodensity exceeding one-third of the middle cerebral artery (MCA) territory on non-contrast CT scan.
  • Intracranial tumor, arteriovenous malformation (AVM), or giant aneurysm.
  • History of intracranial hemorrhagic disease, including but not limited to intracerebral hemorrhage, subarachnoid hemorrhage, etc.
  • History of ischemic stroke, severe head trauma, or intracranial/intraspinal surgery within the past 3 months.
  • Visceral bleeding within the past 3 weeks, including but not limited to gastrointestinal or genitourinary bleeding.
  • Major surgery or severe trauma within the past 2 weeks.
  • Arterial puncture at a non-compressible site within the past week.
  • Systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥100 mmHg despite aggressive antihypertensive treatment.
  • Known significant bleeding tendency or severe coagulation disorder.
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510062, China

RECRUITING

Linyi People's Hospital

Linyi, Shandong, 276002, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Yu Gao

CONTACT

+0518-82342973yu.gao.yg5@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

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 18, 2025

Study Start

October 31, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

November 20, 2025

Record last verified: 2025-10

Locations

CN(2)