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

October 9, 2024 updated by: Genrix (Shanghai) Biopharmaceutical Co., Ltd.

A Multicentre, Randomized, Double-blind, Human Tetanus Immunoglobulin(HTIG) Controlled Phase III Clinical Trail to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity Characteristics of GR2001 Injection for Indication of Prophylaxis Against Tetanus

The goal of this clinical trial is to compare the efficacy and safety of GR2001 injection with Human Tetanus Immunoglobulin(HTIG) in tetanus prophylaxis. Patients will receive either GR2001 injection or HTIG on study D0.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

582

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230601
        • Recruiting
        • The Second Affiliated Hospital of Anhui Medical University
        • Contact:
    • Beijing
      • Beijing, Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
        • Contact:
      • Beijing, Beijing, China, 100050
        • Recruiting
        • Beijing Tiantan Hospital
        • Contact:
      • Beijing, Beijing, China, 100044
        • Recruiting
        • Peking University People Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • The First Affiliated Hospital of Guangzhou Medical University
        • Contact:
      • Guangzhou, Guangdong, China, 510150
        • Recruiting
        • The Third Affiliated Hospital of Guangzhou Medical University
        • Contact:
      • Guangzhou, Guangdong, China, 510280
        • Recruiting
        • Zhujiang Hospital Affiliated to Southern Medical University
        • Contact:
      • Shenzhen, Guangdong, China, 518037
        • Recruiting
        • Shenzhen Second People's Hospital
        • Contact:
    • Guangxi
      • Liuzhou, Guangxi, China, 545006
        • Recruiting
        • Liuzhou People's Hospital
        • Contact:
      • Liuzhou, Guangxi, China, 545025
        • Recruiting
        • Liuzhou Workers's Hospital
        • Contact:
    • Guizhou
      • Zunyi, Guizhou, China, 563000
        • Recruiting
        • The Affiliated Hospital of Zunyi Medical University
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital, Tongji Medical College of HUST
        • Contact:
      • Wuhan, Hubei, China, 430014
        • Recruiting
        • The Central Hospital of Wuhan
        • Contact:
    • Hunan
      • Hengyang, Hunan, China, 421010
        • Recruiting
        • Nanhua Hospital Affiliated to University of south China
        • Contact:
    • Jiangsu
      • Yangzhou, Jiangsu, China, 225009
        • Recruiting
        • The Affiliated Hospital of Yangzhou University
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The Second Affiliated Hospital of Nanchang University
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Recruiting
        • Huashan Hospital, Fudan University
        • Contact:
    • Shanxi
      • Linfen, Shanxi, China, 041000
        • Recruiting
        • Linfen Central Hospital
        • Contact:
      • Yuncheng, Shanxi, China, 044000
        • Recruiting
        • Yuncheng Central Hospital
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310014
        • Recruiting
        • Zhejiang Provincial People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Chinese male or female adults aged ≥ 18 years；
  2. Participants with suspected tetanus exposure (due to dirty or contaminated wounds from various injuries);
  3. Participants who provide signed written informed consent form.

Exclusion Criteria:

  1. Participants known to be allergic to the investigational medicinal product or those suffering from severe allergic conditions；
  2. Suspect or diagnosed as tetanus;
  3. Previously diagnosed as Immunoglobulin A (IgA) deficiency with anti-IgA antibodies；
  4. Prior vaccination history of ≥ 3 doses of tetanus toxoid or tetanus toxoid- containing vaccine;
  5. Females who are pregnant or with pregnancy test positive.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GR2001
If randomized to GR2001, participant will receive a single IM gluteal injection of GR2001
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.
Active Comparator: HTIG
If randomized to HTIG, participant will receive a single IM gluteal injection of HTIG
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The increase of anti-tetanus neutralizing antibody titers (∆ titers)
Time Frame: Baseline up to 12 hours after receipt of Investigational medicinal product.
The proportion of participants with an increase of anti-tetanus neutralizing antibody titers (∆ titers) over protective level.
Baseline up to 12 hours after receipt of Investigational medicinal product.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of tetanus
Time Frame: Up to 105 days after receipt of Investigational medicinal product.
Up to 105 days after receipt of Investigational medicinal product.
To evaluate the safety of GR2001
Time Frame: Up to 105 days after receipt of Investigational medicinal product.
Number of participants with treatment-related adverse events or serious adverse events as assessed by CTCAE v5.0
Up to 105 days after receipt of Investigational medicinal product.
To evaluate the peak plasma concentration(Cmax) of GR2001
Time Frame: Up to 105 days after receipt of Investigational medicinal product.
Up to 105 days after receipt of Investigational medicinal product.
To evaluate the Area under the plasma concentration versus time curve (AUC0-last,AUC0-inf) of GR2001
Time Frame: Up to 105 days after receipt of Investigational medicinal product.
Up to 105 days after receipt of Investigational medicinal product.
To evaluate the immunogenicity of GR2001
Time Frame: Up to 105 days after receipt of Investigational medicinal product.
Up to 105 days after receipt of Investigational medicinal product.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Chuanlin Wang, MD, Peking University People's Hospital
  • Principal Investigator: Zhanfei Li, MD, Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2024

Primary Completion (Estimated)

December 4, 2024

Study Completion (Estimated)

March 4, 2025

Study Registration Dates

First Submitted

October 8, 2024

First Submitted That Met QC Criteria

October 9, 2024

First Posted (Actual)

October 10, 2024

Study Record Updates

Last Update Posted (Actual)

October 10, 2024

Last Update Submitted That Met QC Criteria

October 9, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GR2001-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tetanus

Clinical Trials on GR2001

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe