Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06159101
Status:
RECRUITING
Last Update Posted:
2023-12-06
First Post:
2023-11-28
Brief Title:
A Study to Compare the PK Safety Tolerability and Immunogenicity of HLX13 With YERVOY in Male Subjects
Sponsor:
Shanghai Henlius Biotech
Organization:
Shanghai Henlius Biotech
Study Overview
Official Title:
A Randomized Intravenous Single-Dose Parallel Phase I Clinical Study to Compare the Pharmacokinetic Characteristics Safety and Immunogenicity of HLX13 and YERVOY US- EU- and CN-Sourced in Healthy Chinese Male Subjects
Status:
RECRUITING
Status Verified Date:
2023-11
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:
Phase I Study to Compare the Pharmacokinetic Characteristics Safety Tolerability and Immunogenicity Randomized Double-blind Parallel Controlled of HLX13 with YERVOY Injection in Healthy Chinese Male Subjects
Detailed Description:
This is a randomized intravenous single-dose parallel study to compare the PK characteristics of HLX13 and YERVOY US- EU- and CN-sourced and evaluate their safety tolerability and immunogenicity in healthy Chinese male subjects
This study is divided into two parts Part I is an open-label randomized single-dose parallel study to compare the PK parameters of HLX13 with those of EU-sourced YERVOY in healthy Chinese male subjects after a single intravenous infusion and provide supporting data for the design of Part II This part of the study consists of two groups
Part II is a double-blind randomized single-dose parallel study to evaluate the PK similarity of HLX 13 and YERVOY US- EU- and CN-sourced in healthy Chinese male subjects This part of the study consists of four groups
This study is divided into two parts Part I is an open-label randomized single-dose parallel study to compare the PK parameters of HLX13 with those of EU-sourced YERVOY in healthy Chinese male subjects after a single intravenous infusion and provide supporting data for the design of Part II This part of the study consists of two groups
Part II is a double-blind randomized single-dose parallel study to evaluate the PK similarity of HLX 13 and YERVOY US- EU- and CN-sourced in healthy Chinese male subjects This part of the study consists of four groups
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