Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04868760
Status:
UNKNOWN
Last Update Posted:
2022-10-04
First Post:
2021-04-23
Brief Title:
A Study to Evaluate the Similarity in Pharmacokinetics and Safety of IBI310 and IpilimumabYERVOYin Adult Healthy Chinese Male Volunteers
Sponsor:
Innovent Biologics Suzhou Co Ltd
Organization:
Innovent Biologics Suzhou Co Ltd
Study Overview
Official Title:
Compare the Pharmacokinetics Safety Tolerance and Immunogenicity of Single Doses of IBI310 and Ipilimumab in Healthy Male Subjects a Randomized Double-blind Parallel Controlled Phase I Clinical Study
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
ACTIVE_NOT_RECRUITING
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 trail will investigate the pharmacokinetics and safety of IBI310 and establish pharmacokinetics biosimilarity of IBI310 to ipilimumab YERVOY
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