Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-02-06 @ 3:11 AM
Study NCT ID:
NCT02173392
Status:
COMPLETED
Last Update Posted:
2017-06-20
First Post:
2014-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Bioequivalence Study Comparing a Single 1.5mL Dose of Brodalumab vs. Two Doses (1.0mL + 0.5mL) of Brodalumab
Sponsor:
Bausch Health Americas, Inc.
Organization:
Study Overview
Official Title:
A Bioequivalence Study Comparing a Single Subcutaneous Injection With a 1.5 mL Prefilled Syringe Versus 2 Subcutaneous Injections of 1 mL and 0.5 mL Prefilled Syringes of Brodalumab 140 mg/mL to Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2017-04
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:
A healthy subject, 2-way cross-over study to evaluate the bioequivalence of a single dose of Brodalumab vs. two doses of Brodalumab
Detailed Description:
A healthy subject, 2-way cross-over study to evaluate the bioequivalence of a single 1.5mL dose of Brodalumab (140mg/mL) vs. two doses (1.0mL + 0.5mL) of Brodalumab (140mg/mL)
Study Oversight
Has Oversight DMC:
False
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?: