Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-01-24 @ 9:12 PM
Study NCT ID:
NCT02015156
Status:
COMPLETED
Last Update Posted:
2014-04-23
First Post:
2013-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Evaluating The Safety Of PF-05280014 And Trastuzumab In Healthy Male Volunteers (REFLECTIONS B327-06)
Sponsor:
Pfizer
Organization:
Study Overview
Official Title:
Phase 1, Double-Blind, Randomized, Parallel-Group, Single-Dose, 2-Arm, Safety Study Of PF-05280014 And Trastuzumab Sourced From The US Administered To Healthy Male Volunteers
Status:
COMPLETED
Status Verified Date:
2014-04
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:
This study is to prove that there is no difference in the number of healthy male volunteers that will experience pyrexia (i.e. fever with body temperature of 38°C or higher) within a 24 hour period after administration of a single dose of 6mg/kg of PF-05280014 or trastuzumab sourced from the United States (trastuzumab-US). The study will also compare the safety of both drugs.
Detailed Description:
Safety evaluation.
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 B327-06 | None | None | View |