Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06635798
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
A Phase III Clinical Trail to Evaluate the Efficacy Safety Pharmacokinetics and Immunogenicity Characteristics of GR2001 Injection
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicentre Randomized Double-blind Human Tetanus ImmunoglobulinHTIG Controlled Phase III Clinical Trail to Evaluate the Efficacy Safety Pharmacokinetics and Immunogenicity Characteristics of GR2001 Injection for Indication of Prophylaxis Against Tetanus
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to compare the efficacy and safety of GR2001 injection with Human Tetanus ImmunoglobulinHTIG in tetanus prophylaxis Patients will receive either GR2001 injection or HTIG on study D0
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None