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

Phase 3

Recruiting

• Conditions: Tetanus
• Interventions: Biological: GR2001; Biological: HTIG

• Registration Number: NCT06635798
• Lead Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-09-03
• Study First Submitted: 2024-10-08
• Study First Submitted QC: 2024-10-09
• Last Update Submitted: 2024-10-09
• Study First Posted: 2024-10-10
• Last Update Posted: 2024-10-10
• Primary Completion: 2024-12-04
• Study Completion: 2025-03-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 582

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GR2001	GR2001	If randomized to GR2001, participant will receive a single IM gluteal injection of GR2001
HTIG	HTIG	If randomized to HTIG, participant will receive a single IM gluteal injection of HTIG

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.	Number of participants with treatment-related adverse events or serious adverse events as assessed by CTCAE v5.0
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.

Trial Locations

Locations (1)

The Second Affiliated Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China