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RecruitingNCT06732648Updated Aug 22, 2025

The Efficacy and Safety of HRS8179 in Severe Cerebral Edema Following Large Hemispheric Infarction

A Phase 2/3 interventional study of HRS8179 injection and HRS8179 blank preparation. in Severe Cerebral Edema Following Large Hemispheric Infarction, sponsored by Beijing Suncadia Pharmaceuticals Co., Ltd. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-08-22.

Sponsored by Beijing Suncadia Pharmaceuticals Co., Ltd · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 8 months later.
Phase
Phase 2/3
Study type
Interventional
Enrollment
725
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The study is being conducted to evaluate the efficacy, and safety of HRS8179 injection in preventing and treating severe cerebral edema after large area cerebral infarction in the cerebral hemisphere

02

Conditions studied

  • Severe Cerebral Edema Following Large Hemispheric Infarction
03

In context

Lead sponsor

Beijing Suncadia Pharmaceuticals Co., Ltd is the lead sponsor of 24 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 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);
  2. A clinical diagnosis of acute ischemic stroke in the middle cerebral artery (MCA) territory;
  3. National Institutes of Health Stroke Scale (NIHSS) ≥ 10 at screening;
  4. A large hemispheric infarction defined as: lesion volume of 80 to 160 cm3 on magnetic resonance imaging (MRI) diffusion-weighted imaging (DWI), or computed tomography perfusion (CTP).
  5. The time from onset to treatment must be ≤ 10 hours; if the onset time is unknown, treatment must be initiated within 10 hours after the time last known normal.

Exclusion criteria

Exclusion Criteria:

  1. Theparticipant is likely to withdraw the supportive treatment on the first day;
  2. There is evidence indicating a concurrent infarction in the contralateral hemisphere sufficiently serious to affect functional outcome.
  3. There are clinical signs of brain herniation; CT/MRI indicates a midline shift of >2 mm; CT/MRI indicates cerebral hemorrhage;
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Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
725 participants (estimated)

Study arms

  • Experimental
    Treatment group A: HRS8179 injection

    Drug: HRS8179 injection

  • Experimental
    Treatment group B: HRS8179 injection

    Drug: HRS8179 injection

  • Placebo comparator
    Treatment group C: HRS8179 blank preparation.

    Drug: HRS8179 blank preparation.

Interventions

  • DrugHRS8179 injection

    HRS8179 injection; high dose

  • DrugHRS8179 blank preparation.

    HRS8179 blank preparation.

06

What researchers measure

Primary outcomes

  1. Mortality rate at Day 90

    Time frame: at Day 90

Secondary outcomes

  1. The modified Rankin Scale (mRS) score at Day 90

    Time frame: at Day 90

  2. The proportion of participants who achieved mRS score 0-4 at Day 90

    Time frame: at Day 90

  3. Changes in midline shift from baseline to 72 hours

    Time frame: from baseline to 72 hours

  4. The proportion of participants who meet the indications for decompressive craniectomy by Day 14

    Time frame: Day 14

07

Study locations

1 of 1 sites recruiting
  • Beijing Tiantan Hospital, Capital Medical University
    Beijing, Beijing Municipality 100000, China
    • Liping Liu · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06732648
Lead sponsor
Beijing Suncadia Pharmaceuticals Co., Ltd
Responsible party
Sponsor
First posted
Dec 13, 2024
Start date
Feb 7, 2025
Primary completion
Jun 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Aug 22, 2025

Study contacts

Yu Gao
Contact
yu.gao.yg5@hengrui.com
0518-82342973

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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