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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
582

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 3, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 4, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 4, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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