Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-03-03 @ 5:04 PM
Study NCT ID:
NCT02516618
Status:
COMPLETED
Last Update Posted:
2016-05-12
First Post:
2015-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Fasinumab (REGN475) in Healthy Japanese and Caucasian Subjects
Sponsor:
Regeneron Pharmaceuticals
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of Fasinumab in Healthy Japanese and Caucasian Subjects
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:
The primary objective of the study is to assess the safety and tolerability of a single dose of subcutaneous (SC) or intravenous (IV) administered fasinumab in healthy Japanese subjects.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: