Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06302374
Status:
COMPLETED
Last Update Posted:
2024-03-08
First Post:
2024-02-28
Brief Title:
Safety Tolerability Pharmacokinetics Pharmacodynamics and Immunogenicity of GR2001 in Chinese Healthy Adults
Sponsor:
Genrix Shanghai Biopharmaceutical Co Ltd
Organization:
Genrix Shanghai Biopharmaceutical Co Ltd
Study Overview
Official Title:
A Multicentre Randomized Double-Blind Placebo-Controlled Phase III Study to Evaluate the Safety Tolerability Pharmacokinetics Pharmacodynamics and Immunogenicity of GR2001 Injection in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 HTIGin healthy adult subjects
Detailed Description:
This is a Multicentre Randomized Double-Blind Placebo-Controlled Phase III 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 111222The phase II part will last for 105 days following the assessments of safety PK PD and ADA
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 111222The phase II part will last for 105 days following the assessments of safety PK PD and ADA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None