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NCT Number: NCT06635798

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

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.

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Key information

Conditions

Tetanus Bacterial Infections Bacterial Infections and Mycoses Clostridium Infections Gram-Positive Bacterial Infections Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

GR2001

Biological

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.

HTIG

Biological

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. The incidence of tetanus

    Time frame: Up to 105 days after receipt of Investigational medicinal product.

  2. 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

  3. To evaluate the peak plasma concentration(Cmax) of GR2001

    Time frame: Up to 105 days after receipt of Investigational medicinal product.

  4. 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.

  5. To evaluate the immunogenicity of GR2001

    Time frame: Up to 105 days after receipt of Investigational medicinal product.

Study contacts

Contact information is provided by the study sponsor or research team.

Chuanlin Wang, MD

CONTACT

[email protected]

86+13911883012

Sponsors and collaborators

Lead sponsor

Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Oct 10, 2024
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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