Safety, Tolerability, and Preliminary Efficacy of HRS-7450 Injection in the Treatment of Acute Ischemic Stroke: a Multi-center, Randomized, Double-blind, Double-dummy, Placebo-controlled Clinical Trial

NCT06447415 | Completed Phase 1

• 1 other identifier: HRS-7450-102
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a multi-center, randomized, double-blind, double-dummy, placebo-controlled, single dose escalation study aimed at evaluating the overall safety, tolerability, and preliminary efficacy of HRS-7450 in patients with acute ischemic stroke.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Symptomatic Intracranial Hemorrhage within 36 hours after the start of administration, The incidence of sICH

  within 36 hours after the start of administration

Secondary Outcomes (11)

• 7 day mortality rate after administration

  within 7days after the start of administration

• The incidence of sICH 7 days after administration

  within 7days after the start of administration

• The incidence of ICH 7 days after administration

  within 7days after the start of administration

• The incidence of systemic bleeding 7 days after administration

  within 7days after the start of administration

• Effective reperfusion rate measured by 24-hour PWI or CTP

  within 24 hours after the start of administration

Study Arms (2)

HRS-7450

EXPERIMENTAL

Drug: HRS-7450

0.9% sodium chloride injection

PLACEBO COMPARATOR

Drug: 0.9% sodium chloride injection

Interventions

HRS-7450 DRUG

HRS-7450 Injection

HRS-7450

0.9% sodium chloride injection DRUG

0.9% sodium chloride injection

0.9% sodium chloride injection

Eligibility Criteria

• Age: 18 Years - 80 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 study, and sign an informed consent form (the informed consent form can be voluntarily signed by the individual or legal representative);
• ≤ Age ≤ 80 years old;
• The onset time is within 4.5 to 24 hours, and medication can be completed within 24 hours of onset (onset time is defined as the patient's last normal time);
• Clinically diagnosed as acute ischemic stroke (diagnosis follows the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023);
• mRS score ≤ 2 before the first episode;
• When screening, the National Institutes of Health Stroke Scale (NIHSS) scores from 3 to 25 (including both ends);
• Female and male participants with fertility must agree to use efficient contraception measures from the signing of the informed consent form until one month after the last administration of the investigational drug, without a birth plan, and without donating sperm/eggs. (See "Contraceptive methods" in the attachment for details).

You may not qualify if:

• Treatment with ateplase, teneplase, or other thrombolytic drugs;
• Proposed endovascular treatment;
• Intracranial hemorrhagic diseases;
• Aortic arch dissection;
• NIHSS awareness score 1a\>2 points;
• Epileptic seizures or neurological dysfunction after seizures, or combined with other neurological/psychiatric disorders leading to uncooperative or non cooperative physical examinations;
• Non enhanced CT shows a low-density shadow greater than one-third of the blood supply area of the middle cerebral artery or an ASPECT score of less than 6 points in the anterior circulation;
• Previous history of intracranial hemorrhage;
• Intracranial tumors, arteriovenous malformations, and giant aneurysms;
• Acute occlusion of the internal carotid artery due to carotid artery dissection;
• Multiple infarcts in areas supplied by multiple large blood vessels;
• Have a history of ischemic stroke, severe traumatic brain injury, or intracranial or spinal surgery in the past month;
• Gastrointestinal or urinary system bleeding within the past 2 weeks;
• Major surgical procedures or severe injuries within the past 2 weeks;
• Arterial puncture that is difficult to compress and stop bleeding within the past week;

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Sun Yat sen University

Guangzhou, Guangdong, 510062, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• 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: Multi-center, randomized, double-blind and double simulated, placebo controlled, single dose escalation

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 7, 2024
• Study Start: August 6, 2024
• Primary Completion: March 18, 2025
• Study Completion: June 11, 2025
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

CN (1)