SPT-07A Injection in Patients With Acute Ischemic Stroke (AIS): A Phase III Clinical Trial

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel controlled clinical trial in Chinese patients with acute ischemic stroke. Objective to evaluate the efficacy and safety of SPT-07A injection compared with placebo in the treatment of patients with acute ischemic stroke.

Conditions

• Stroke, Acute

Interventions

DRUG

SPT-07A injection

20mg (2), dissolved in 250ml of normal saline, and injected intravenously for 90±20min, twice a day, and administered for 7 days.

OTHER

placebo

2 Injection simulants, dissolved in 250ml of normal saline, and injected intravenously for 90±20min, twice a day, and administered for 7 days.

Sponsors & Collaborators

• Suzhou Huyun New Drug Research and Development Co., Ltd

  collaborator UNKNOWN

• Shanghai Canming Pharmaceutical Technology Co., Ltd

  collaborator UNKNOWN

• Beijing Haijinge Pharmaceutical Technology Co., Ltd

  collaborator UNKNOWN

• The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology

  collaborator UNKNOWN

• Xiang Yang NO.1 People's Hospital

  collaborator UNKNOWN

• Xiangyang Central Hospital

  collaborator OTHER

• Wuhan NO. 4 hospital

  collaborator UNKNOWN

• The Affiliated Hospital of Xuzhou Medical University

  collaborator OTHER

• Xuzhou Central Hospital

  collaborator OTHER

• Yan'an University Xianyang hospital Co., Ltd

  collaborator UNKNOWN

• Hengshui People's Hospital

  collaborator OTHER

• Inner Mongolia Baogang Hospital

  collaborator OTHER

• Daqing oilfield general hospital

  collaborator UNKNOWN

• The Fourth Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• The First Hospital of Jilin University

  collaborator OTHER

• Meihekou Central Hospital

  collaborator UNKNOWN

• Jiangsu Taizhou People's Hospital

  collaborator OTHER

• Tianjin People's Hospital

  collaborator OTHER

• Taizhou Hospital

  collaborator OTHER

• Zhejiang Taizhou hospital

  collaborator UNKNOWN

• The First Affiliated Hospital of Nanhua University

  collaborator UNKNOWN

• Jining Medical University

  collaborator OTHER

• Zhongshan Hospital Xiamen University

  collaborator OTHER

• Neijiang Second People's Hospital

  collaborator UNKNOWN

• Tancheng first people's Hospital

  collaborator UNKNOWN

• The Affiliated Hospital of Qingdao University

  collaborator OTHER

• Taian Central Hospital

  collaborator UNKNOWN

• Weihai Municipal Hospital

  collaborator OTHER

• Nanyang nanshai hospital

  collaborator UNKNOWN

• Dezhou People's Hospital

  collaborator OTHER

• The First Affiliated Hospital of Nanyang Medical College

  collaborator UNKNOWN

• Deyang People's Hospital

  collaborator OTHER

• Yantai Yuhuangding Hospital

  collaborator OTHER

• Qingdao Central Hospital

  collaborator OTHER

• Fukuang General Hospital of Liaoning health industry group

  collaborator UNKNOWN

• Xi'an Gaoxin Hospital

  collaborator OTHER

• Affiliated Hospital of Jiaxing University

  collaborator OTHER

• Fujian Zhangzhou hospital

  collaborator UNKNOWN

• The Affiliated Hospital of Inner Mongolia Medical University

  collaborator OTHER

• Daqing people's Hospital

  collaborator UNKNOWN

• Hainan People's Hospital

  collaborator OTHER

• Qujing first people's Hospital

  collaborator UNKNOWN

• The Third Affiliated Hospital of Qiqihar Medical College

  collaborator UNKNOWN

• The First Affiliated Hospital of Hebei North University

  collaborator OTHER

• Linfen Central Hospital

  collaborator UNKNOWN

• Xuancheng people's hospital

  collaborator UNKNOWN

• The First Affiliated Hospital of Shihezi University Medical College

  collaborator UNKNOWN

• Guangzhou Red Cross Hospital

  collaborator OTHER

• People's Hospital of Wuhan University

  collaborator UNKNOWN

• Wuhan Central Hospital

  collaborator OTHER

• Jingzhou Central Hospital

  collaborator OTHER

• The Central Hospital of Huanggang

  collaborator OTHER

• Sinopharm Dongfeng General Hospital

  collaborator UNKNOWN

• Changjiang Shipping General Hospital

  collaborator UNKNOWN

• Yichang Central People's Hospital

  collaborator OTHER

• The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture

  collaborator OTHER

• Xiangtan Central Hospital

  collaborator OTHER

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  lead OTHER

Principal Investigators

• Bo Hu, Dr. or PhD. · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-20

Primary Completion

2024-01-10

Completion

2024-01-10

Countries

• China

Study Locations