Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-31 @ 5:01 AM
Study NCT ID:
NCT01638104
Status:
COMPLETED
Last Update Posted:
2017-10-13
First Post:
2012-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ANX-042 Healthy Volunteer Dose Escalation Study
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
ANX-042 Healthy Volunteer Dose Escalation Study
Status:
COMPLETED
Status Verified Date:
2017-10
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:
The purpose of this study was to investigate the safety and tolerability of ANX-042 when administered by continuous intravenous (IV) infusion in healthy volunteers.
Detailed Description:
Each participant received a total of two, approximately 12-hour continuous infusions of ANX-042 and one 12-hour continuous infusion of placebo, with a 36-hour washout period between treatments.
This study was conducted by Anexon, Inc. at Celerion, in Lincoln, Nebraska.
This study was conducted by Anexon, Inc. at Celerion, in Lincoln, Nebraska.
Study Oversight
Has Oversight DMC:
False
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?: