Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06309043
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-03-07
Brief Title:
A Randomized Single Intravenous Dose Parallel Phase I Clinical Study to Compare the Pharmacokinetic Characteristics Safety and Immunogenicity of HLX05 Vs Erbitux Cetuximab in Healthy Adult Male Chinese Subjects
Sponsor:
Shanghai Henlius Biotech
Organization:
Shanghai Henlius Biotech
Study Overview
Official Title:
A Randomized Single Intravenous Dose Parallel Phase I Clinical Study to Compare the Pharmacokinetic Characteristics Safety and Immunogenicity of HLX05 Vs Erbitux Cetuximab in Healthy Adult Male Chinese Subjects
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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:
This is a randomized single intravenous dose parallel study to compare the PK characteristics safety tolerability and immunogenicity of HLX05 vs Erbitux US- EU- and CN-sourced in healthy adult male Chinese subjects This study is divided into two parts
Detailed Description:
None
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