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

NCT06635798 | Recruiting Phase 3

• 1 other identifier: GR2001-002
• Study Type: interventional
• Target: 582
• Locations: 1 country
• Sites: 20

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.

Conditions

Tetanus

Keywords

Tetanus; Human Tetanus Immunoglobulin; GR2001 Injection

Outcome Measures

Primary Outcomes (1)

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

  The proportion of participants with an increase of anti-tetanus neutralizing antibody titers (∆ titers) over protective level.

  Baseline up to 12 hours after receipt of Investigational medicinal product.

Secondary Outcomes (5)

• The incidence of tetanus

  Up to 105 days after receipt of Investigational medicinal product.

• To evaluate the safety of GR2001

  Up to 105 days after receipt of Investigational medicinal product.

• To evaluate the peak plasma concentration(Cmax) of GR2001

  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

  Up to 105 days after receipt of Investigational medicinal product.

• To evaluate the immunogenicity of GR2001

  Up to 105 days after receipt of Investigational medicinal product.

Study Arms (2)

GR2001

EXPERIMENTAL

If randomized to GR2001, participant will receive a single IM gluteal injection of GR2001

Biological: GR2001

HTIG

ACTIVE COMPARATOR

If randomized to HTIG, participant will receive a single IM gluteal injection of HTIG

Biological: HTIG

Interventions

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.

GR2001

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.

HTIG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genrix (Shanghai) Biopharmaceutical Co., Ltd.: lead

Study Sites (20)

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

RECRUITING

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Peking University People Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100050, China

RECRUITING

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

RECRUITING

The Third Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510150, China

RECRUITING

Zhujiang Hospital Affiliated to Southern Medical University

Guangzhou, Guangdong, 510280, China

RECRUITING

Shenzhen Second People's Hospital

Shenzhen, Guangdong, 518037, China

RECRUITING

Liuzhou People's Hospital

Liuchow, Guangxi, 545006, China

RECRUITING

Liuzhou Workers's Hospital

Liuchow, Guangxi, 545025, China

RECRUITING

The Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, 563000, China

RECRUITING

The Central Hospital of Wuhan

Wuhan, Hubei, 430014, China

RECRUITING

Tongji Hospital, Tongji Medical College of HUST

Wuhan, Hubei, 430030, China

RECRUITING

Nanhua Hospital Affiliated to University of south China

Hengyang, Hunan, 421010, China

RECRUITING

The Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, 225009, China

RECRUITING

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

RECRUITING

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Linfen Central Hospital

Linfen, Shanxi, 041000, China

RECRUITING

Yuncheng Central Hospital

Yuncheng, Shanxi, 044000, China

RECRUITING

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310014, China

RECRUITING

MeSH Terms

Conditions

Tetanus

Condition Hierarchy (Ancestors)

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

Study Officials

• Chuanlin Wang, MD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

• Zhanfei Li, MD

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chuanlin Wang, MD

CONTACT

86+13911883012; wangchuanlinvip@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 10, 2024
• Study Start: September 3, 2024
• Primary Completion: December 4, 2024
• Study Completion: March 4, 2025
• Last Updated: October 10, 2024

Record last verified: 2024-09

Locations

CN (20)