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

Last updated: October 9, 2024
Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Hypoparathyroidism

Treatment

HTIG

GR2001

Clinical Study ID

NCT06635798
GR2001-002
  • Ages > 18
  • All Genders

Study Summary

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 Criteria

Inclusion

Inclusion Criteria:

  1. Chinese male or female adults aged ≥ 18 years;

  2. Participants with suspected tetanus exposure (due to dirty or contaminated woundsfrom various injuries);

  3. Participants who provide signed written informed consent form.

Exclusion

Exclusion Criteria:

  1. Participants known to be allergic to the investigational medicinal product or thosesuffering 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 Design

Total Participants: 582
Treatment Group(s): 2
Primary Treatment: HTIG
Phase: 3
Study Start date:
September 03, 2024
Estimated Completion Date:
March 04, 2025

Connect with a study center

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui 230601
    China

    Active - Recruiting

  • Beijing Tiantan Hospital

    Beijing, Beijing 100050
    China

    Active - Recruiting

  • Peking University First Hospital

    Beijing, Beijing 100034
    China

    Active - Recruiting

  • Peking University People Hospital

    Beijing, Beijing 100044
    China

    Active - Recruiting

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong 510120
    China

    Active - Recruiting

  • The Third Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong 510150
    China

    Active - Recruiting

  • Zhujiang Hospital Affiliated to Southern Medical University

    Guangzhou, Guangdong 510280
    China

    Active - Recruiting

  • Shenzhen Second People's Hospital

    Shenzhen, Guangdong 518037
    China

    Active - Recruiting

  • Liuzhou People's Hospital

    Liuzhou, Guangxi 545006
    China

    Active - Recruiting

  • Liuzhou Workers's Hospital

    Liuzhou, Guangxi 545025
    China

    Active - Recruiting

  • The Affiliated Hospital of Zunyi Medical University

    Zunyi, Guizhou 563000
    China

    Active - Recruiting

  • The Central Hospital of Wuhan

    Wuhan, Hubei 430014
    China

    Active - Recruiting

  • Tongji Hospital, Tongji Medical College of HUST

    Wuhan, Hubei 430030
    China

    Active - Recruiting

  • Nanhua Hospital Affiliated to University of south China

    Hengyang, Hunan 421010
    China

    Active - Recruiting

  • The Affiliated Hospital of Yangzhou University

    Yangzhou, Jiangsu 225009
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330006
    China

    Active - Recruiting

  • Huashan Hospital, Fudan University

    Shanghai, Shanghai 200040
    China

    Active - Recruiting

  • Linfen Central Hospital

    Linfen, Shanxi 041000
    China

    Active - Recruiting

  • Yuncheng Central Hospital

    Yuncheng, Shanxi 044000
    China

    Active - Recruiting

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang 310014
    China

    Active - Recruiting

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