Clinical trial NCT06635798: A Phase III Clinical Trail to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity Characteristics of GR2001 Injection
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Tetanus
Keywords: Tetanus
Human Tetanus Immunoglobulin
GR2001 Injection
Lead sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-10-10
Enrollment: 582
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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 outcomes:
measure: The increase of anti-tetanus neutralizing antibody titers (∆ titers)
timeFrame: Baseline up to 12 hours after receipt of Investigational medicinal product.
Secondary outcomes:
measure: The incidence of tetanus
timeFrame: Up to 105 days after receipt of Investigational medicinal product.
measure: To evaluate the safety of GR2001
timeFrame: Up to 105 days after receipt of Investigational medicinal product.
measure: To evaluate the peak plasma concentration(Cmax) of GR2001
timeFrame: Up to 105 days after receipt of Investigational medicinal product.
measure: To evaluate the Area under the plasma concentration versus time curve (AUC0-last,AUC0-inf) of GR2001
timeFrame: Up to 105 days after receipt of Investigational medicinal product.
measure: To evaluate the immunogenicity of GR2001
timeFrame: Up to 105 days after receipt of Investigational medicinal product.
Other outcomes:
Locations:
city: Hefei
country: China
facility: The Second Affiliated Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University People Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Zhujiang Hospital Affiliated to Southern Medical University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
state: Guangdong
city: Liuzhou
country: China
facility: Liuzhou People's Hospital
state: Guangxi
city: Liuzhou
country: China
facility: Liuzhou Workers's Hospital
state: Guangxi
city: Zunyi
country: China
facility: The Affiliated Hospital of Zunyi Medical University
state: Guizhou
city: Wuhan
country: China
facility: The Central Hospital of Wuhan
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College of HUST
state: Hubei
city: Hengyang
country: China
facility: Nanhua Hospital Affiliated to University of south China
state: Hunan
city: Yangzhou
country: China
facility: The Affiliated Hospital of Yangzhou University
state: Jiangsu
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University
state: Shanghai
city: Linfen
country: China
facility: Linfen Central Hospital
state: Shanxi
city: Yuncheng
country: China
facility: Yuncheng Central Hospital
state: Shanxi
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
Study officials:
affiliation: Peking University People's Hospital
name: Chuanlin Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tongji Hospital
name: Zhanfei Li, MD
role: PRINCIPAL_INVESTIGATOR
References: