A Phase III Clinical Trail to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity Characteristics of GR2001 Injection

PHASE3RecruitingINTERVENTIONAL
Enrollment

582

Participants

Timeline

Start Date

September 3, 2024

Primary Completion Date

December 4, 2024

Study Completion Date

March 4, 2025

Conditions
Tetanus
Interventions
BIOLOGICAL

GR2001

The packaging for GR2001 injection uses a borosilicate glass vial, a brominated halobutyl rubber stopper for injectable solutions and an aluminum-plastic combination cap for antibiotic vials as its primary packaging materials. The specification is 5mg/1ml per vial.

BIOLOGICAL

HTIG

The HTIG is a Chinese licensed Human Tetanus Immunoglobulin produced by Tonglu-Bio, which are derived from human plasma, and then purified and filled in the injectable vial form.

Trial Locations (20)

100034

RECRUITING

Peking University First Hospital, Beijing

100044

RECRUITING

Peking University People Hospital, Beijing

100050

RECRUITING

Beijing Tiantan Hospital, Beijing

200040

RECRUITING

Huashan Hospital, Fudan University, Shanghai

225009

RECRUITING

The Affiliated Hospital of Yangzhou University, Yangzhou

230601

RECRUITING

The Second Affiliated Hospital of Anhui Medical University, Hefei

310014

RECRUITING

Zhejiang Provincial People's Hospital, Hangzhou

330006

RECRUITING

The Second Affiliated Hospital of Nanchang University, Nanchang

421010

RECRUITING

Nanhua Hospital Affiliated to University of south China, Hengyang

430014

RECRUITING

The Central Hospital of Wuhan, Wuhan

430030

RECRUITING

Tongji Hospital, Tongji Medical College of HUST, Wuhan

510120

RECRUITING

The First Affiliated Hospital of Guangzhou Medical University, Guangzhou

510150

RECRUITING

The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou

510280

RECRUITING

Zhujiang Hospital Affiliated to Southern Medical University, Guangzhou

518037

RECRUITING

Shenzhen Second People's Hospital, Shenzhen

545006

RECRUITING

Liuzhou People's Hospital, Liuzhou

545025

RECRUITING

Liuzhou Workers's Hospital, Liuzhou

563000

RECRUITING

The Affiliated Hospital of Zunyi Medical University, Zunyi

041000

RECRUITING

Linfen Central Hospital, Linfen

044000

RECRUITING

Yuncheng Central Hospital, Yuncheng

All Listed Sponsors
lead

Genrix (Shanghai) Biopharmaceutical Co., Ltd.

INDUSTRY