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Recruiting NCT06635798

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

Phase III Interventional Tetanus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GR2001, HTIG.
Who it may be relevant to
Registry conditions: Tetanus. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

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.

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.

Primary outcome measures

  • The increase of anti-tetanus neutralizing antibody titers (∆ titers) [Time frame: Baseline up to 12 hours after receipt of Investigational medicinal product.]
Secondary outcome measures (5)
  • The incidence of tetanus [Time frame: 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.]
  • To evaluate the peak plasma concentration(Cmax) of GR2001 [Time frame: 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.]
  • To evaluate the immunogenicity of GR2001 [Time frame: Up to 105 days after receipt of Investigational medicinal product.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

China · 20 centers
  • The Second Affiliated Hospital of Anhui Medical University — Hefei
  • Peking University First Hospital — Beijing
  • Peking University People Hospital — Beijing
  • Beijing Tiantan Hospital — Beijing
  • The First Affiliated Hospital of Guangzhou Medical University — Guangzhou
  • The Third Affiliated Hospital of Guangzhou Medical University — Guangzhou
  • Zhujiang Hospital Affiliated to Southern Medical University — Guangzhou
  • Shenzhen Second People's Hospital — Shenzhen
  • … and 12 more centers

Identifiers

NCT: NCT06635798 · GR2001-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗