Ignite Creation Date:
2024-05-06 @ 8:39 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02792686
Status:
COMPLETED
Last Update Posted:
2024-05-17
First Post:
2016-05-30
Brief Title:
ABX464 First in Man Study
Sponsor:
Abivax SA
Organization:
Abivax SA
Study Overview
Official Title:
ABX464 First in Man Open Label Parallel Group Single Ascending Dose Study
Status:
COMPLETED
Status Verified Date:
2016-05
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 an open label parallel group single ascending dose exploratory study performed in a single site Centre Cap Montpellier France
Detailed Description:
This study is an open label parallel group single ascending dose exploratory study performed in a single site Centre Cap Montpellier France Six subjects per dose group were enrolled into 1 of 4 groups with escalating doses of ABX464 50 100 150 and 200 mg For each dose group a first subject was treated if no adverse event AE occurred a second subject was dosed one hour later The four last subjects were dosed the day after if no clinically significant AE occurred Escalation to the following dose level was decided after review of PK and safety data laboratory results ECG vital signs and AEs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None