Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06400719
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-04-24
Brief Title:
Pilot Study of AVT16 in Healthy Adult Subjects
Sponsor:
Alvotech Swiss AG
Organization:
Alvotech Swiss AG
Study Overview
Official Title:
An Open Label Single Arm Pilot Study to Investigate the Safety and Tolerability of a Single 300mg Intravenous Dose of AVT16 in Healthy Adult Subjects Aged 18 to 55 Years Inclusive
Status:
ACTIVE_NOT_RECRUITING
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:
This is a pilot study in healthy adult subjects to evaluate the safety and tolerability of AVT16 after administration of a single intravenous administration Pharmacokinetics and immunogenicity of AVT16 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