Ignite Creation Date:
2024-07-17 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06484855
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-26
Brief Title:
Safety and Tolerability of IBI355 in Patients With Primary Sjogrens Syndrome
Sponsor:
Innovent Biologics Suzhou Co Ltd
Organization:
Innovent Biologics Suzhou Co Ltd
Study Overview
Official Title:
A Double Blind Randomized Study Assessing the Safety Tolerability Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of IBI355 in Patients With Primary Sjogrens Syndrome
Status:
RECRUITING
Status Verified Date:
2024-08
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 study aims to evaluate the safety tolerability pharmacokinetics and pharmacodynamics of multiple ascending doses of IBI355 in primary Sjogrens syndrome pSS patients This study also aims to evaluate the anti-Drug antibody after multiple ascending doses of IBI355 in pSS patients
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