Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2026-02-28 @ 8:19 AM
Study NCT ID:
NCT03621605
Status:
TERMINATED
Last Update Posted:
2024-12-13
First Post:
2018-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase1 Study of VIB9600
Sponsor:
Amgen
Organization:
Study Overview
Official Title:
A Phase 1 Randomized, Blinded, Placebo-controlled Study to Evaluate the Safety and Tolerability of Single and Multiple Ascending Doses of VIB9600 by Intravenous Infusion or Subcutaneous Injection in Healthy Subjects
Status:
TERMINATED
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated due to tolerability issues.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Overall design: Single-center, randomized, blinded, placebo-controlled single- and multiple-ascending dose study in healthy adult subjects.
Detailed Description:
This first-time-in-human (FTIH) SAD and MAD studies in healthy adult subjects will be conducted at one site in the United States of America (USA) on IV and SC VIB9600.
Study acquired from Horizon in 2024. Originally Viela Bio was the sponsor.
Study acquired from Horizon in 2024. Originally Viela Bio was the sponsor.
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?: