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

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

Recruiting
18 years and older
All
Phase 3

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Overview

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.

Eligibility

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 toxoidcontaining vaccine;
  5. Females who are pregnant or with pregnancy test positive.

Study details
    Tetanus

NCT06635798

Genrix (Shanghai) Biopharmaceutical Co., Ltd.

21 October 2025

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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