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Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of GR2001 in Chinese Healthy Adults

NCT06302374 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2024-03-08

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and Immunogenicity characteristics of GR2001 and compare the anti-tetanus neutralizing antibody titers of GR2001 with human tetanus immunoglobulin (HTIG)in healthy adult subjects.

Conditions

  • Tetanus

Interventions

BIOLOGICAL

GR2001

intramuscular injection

BIOLOGICAL

Placebo

intramuscular injection

BIOLOGICAL

HTIG

intramuscular injection

BIOLOGICAL

Tetanus Toxoid

intramuscular injection

Sponsors & Collaborators

  • Genrix (Shanghai) Biopharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jing Zhang, PHD · Huashan Hospital affiliated of Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-04
Primary Completion
2023-11-01
Completion
2024-02-19

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06302374 on ClinicalTrials.gov