Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05928585
Status:
COMPLETED
Last Update Posted:
2024-07-01
First Post:
2023-06-12
Brief Title:
A Study of Safety and Drug Levels of HIB210 in Healthy Volunteers
Sponsor:
HI-Bio
Organization:
HI-Bio
Study Overview
Official Title:
Phase 1 Study to Assess Safety Tolerability Pharmacokinetics and Pharmacodynamics of HIB210 in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2024-06
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:
The goal of this clinical trial is to test safety of the investigational product in healthy volunteers The main questions it aims to answer is when HIB210 is administered as multiple doses is it
1 Safe
2 Well tolerated
3 Does the body absorb and eliminate HIB210 as expected
1 Safe
2 Well tolerated
3 Does the body absorb and eliminate HIB210 as expected
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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