NCT06302374

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

A Multicentre, Randomized, Double-Blind, Placebo-Controlled, Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of GR2001 Injection in Healthy Subjects

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a Multicentre, Randomized, Double-Blind, Placebo-Controlled, Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of GR2001 Injection in Healthy Subjects. In the phase I part of the study, a total of 94 healthy subjects will be enrolled. The 94 healthy adult subjects will be enrolled into 7 cohorts sequentially. Each participant will receive a single IM dose of GR2001 or placebo or HTIG according to the cohort in which they were enrolled. After injection (Day 0), participants will remain in the study site for observation up to Day 1. The phase I part will last for 105 days following the assessments of safety, PK, PD and ADA. In the phase II part of the study, a total of 108 healthy subjects will be enrolled. The 108 healthy subjects will be randomly assigned to the experimental group and the control group based on a ratio of 1:1:1:2:2:2.The phase II part will last for 105 days following the assessments of safety, PK, PD and ADA.

Conditions

• Tetanus

Interventions

Type	Name	Description
BIOLOGICAL	GR2001	intramuscular injection
BIOLOGICAL	Placebo	intramuscular injection
BIOLOGICAL	HTIG	intramuscular injection
BIOLOGICAL	Tetanus Toxoid	intramuscular injection

Timeline

• Start date: 2023-03-04
• Primary completion: 2023-11-01
• Completion: 2024-02-19
• First posted: 2024-03-08
• Last updated: 2024-03-08

Locations

1 site across 1 country: China