Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2025-12-25 @ 2:48 PM
Study NCT ID:
NCT04779892
Status:
COMPLETED
Last Update Posted:
2021-10-11
First Post:
2021-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Study of Infliximab (CMAB008 and Remicade) in Healthy Subjects to Compare the PK and Safety
Sponsor:
Taizhou Mabtech Pharmaceutical Co.,Ltd
Organization:
Study Overview
Official Title:
The Study of Infliximab (CMAB008 and Remicade) in Healthy Subjects to Compare the PK and Safety
Status:
COMPLETED
Status Verified Date:
2021-01
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:
A phase 1, Randomized, Double-blind, Parallel group, Sing-dose study to compare the Pharmacokinetics and Safety of CMAB008 and Remicade in healthy subjects.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: