Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-02 @ 4:24 AM
Study NCT ID:
NCT01844804
Status:
COMPLETED
Last Update Posted:
2014-01-07
First Post:
2013-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pharmacokinetics Study Comparing PF-06438179 and Infliximab in Healthy Volunteers (REFLECTIONS B537-01)
Sponsor:
Pfizer
Organization:
Study Overview
Official Title:
Phase 1, Double Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Comparative Pharmacokinetic Study of PF-06438179 and Infliximab Sourced From US and EU Administered to Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2014-01
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:
In this study, healthy volunteers will receive a single intravenous dose of either PF-06438179 or infliximab (United States) or infliximab (European Union). During the course of the study, the pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms of PF-06438179 and the licensed infliximab products. Safety, tolerability, and immunologic response will also be evaluated throughout.
Detailed Description:
None
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| REFLECTIONS B537-01 | None | None | View |