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

NCT06635798 · tracked via the Priya Life Science China tracker

Sponsor

Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Phase

Phase 3

Started

2024-09-03

Last updated

2024-10-10

Condition(s) studied

Tetanus

Investigational drug(s) / intervention(s)

GR2001HTIG

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.

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.

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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

The increase of anti-tetanus neutralizing antibody titers (∆ titers) — 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.

Trial sites (20)

Facility	City	Region	Status
The Second Affiliated Hospital of Anhui Medical University	Hefei	Anhui	Recruiting
Peking University First Hospital	Beijing	Beijing Municipality	Recruiting
Peking University People Hospital	Beijing	Beijing Municipality	Recruiting
Beijing Tiantan Hospital	Beijing	Beijing Municipality	Recruiting
The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong	Recruiting
The Third Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong	Recruiting
Zhujiang Hospital Affiliated to Southern Medical University	Guangzhou	Guangdong	Recruiting
Shenzhen Second People's Hospital	Shenzhen	Guangdong	Recruiting
Liuzhou People's Hospital	Liuzhou	Guangxi	Recruiting
Liuzhou Workers's Hospital	Liuzhou	Guangxi	Recruiting
The Affiliated Hospital of Zunyi Medical University	Zunyi	Guizhou	Recruiting
The Central Hospital of Wuhan	Wuhan	Hubei	Recruiting
Tongji Hospital, Tongji Medical College of HUST	Wuhan	Hubei	Recruiting
Nanhua Hospital Affiliated to University of south China	Hengyang	Hunan	Recruiting
The Affiliated Hospital of Yangzhou University	Yangzhou	Jiangsu	Recruiting
The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi	Recruiting
Huashan Hospital, Fudan University	Shanghai	Shanghai Municipality	Recruiting
Linfen Central Hospital	Linfen	Shanxi	Recruiting
Yuncheng Central Hospital	Yuncheng	Shanxi	Recruiting
Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06635798 on ClinicalTrials.gov ↗ ← All trials in China