Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06641388
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-12
Brief Title:
A Study Evaluating the Single Subcutaneous Injection of Ebronucimab in Chinese Healthy Male Subjects
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase I Study Evaluating the Single Subcutaneous Injection of Ebronucimab With Different Production Processes in Chinese Healthy Male Subjects
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
This is a phase I clinical study to evaluate the pharmacokinetics PK similarity of single dose subcutaneous injection of Ebronucimab with different production processes in Chinese healthy male subjects
Detailed Description:
This is a randomized parallel controlled phase I clinical study to evaluate the pharmacokinetics PK similarity of single dose subcutaneous injection of Ebronucimab with different production processes in Chinese healthy male subjects This study consists of two parts pre-trial part and formal-trial part with a planned enrollment of approximately 180 healthy male participants from China
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