Ignite Creation Date:
2024-05-06 @ 7:44 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06110338
Status:
COMPLETED
Last Update Posted:
2023-10-31
First Post:
2023-10-26
Brief Title:
Safety and Tolerance Study of IBI355 in Health Volunteers
Sponsor:
Innovent Biologics Suzhou Co Ltd
Organization:
Innovent Biologics Suzhou Co Ltd
Study Overview
Official Title:
A Phase 1 Double-blind Study to Evaluate the Safety and Tolerability of a Single-dose Administration of IBI355 in Health Adults
Status:
COMPLETED
Status Verified Date:
2024-10
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 is being done to find out if IBI355 is safe and tolerance in health volunteers The study will test increasing single doses of IBI355 given to adult health volunteers The goal is to confirmed the safety of the highest dose of IBI355 or to find out the highest dose of IBI35 that can be given to health volunteer that dose not cause unacceptable side effects Different dose regimens will be evaluated The pharmacokinetics and ADA of IBI355 will also be evaluated
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