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NCT02015156 · ClinicalTrials.gov registry record · Phase 1
A Study Evaluating The Safety Of PF-05280014 And Trastuzumab In Healthy Male Volunteers (REFLECTIONS B327-06)
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 162
- Enrollment target
NCT02015156 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 162 participants.
The verdict
NCT02015156, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 162 participants
- Enrollment target
Study 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.
Interventions
- BIOLOGICAL PF-05280014
- BIOLOGICAL Herceptin®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 162 participants |
| Start Date | 2014-01 |
| Est. Completion | 2014-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02015156
The ClinicalTrials.gov registry entry for NCT02015156 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 162 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which PF-05280014 is the first listed.
NCT02015156 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02015156 about?
NCT02015156 is a clinical study titled "A Study Evaluating The Safety Of PF-05280014 And Trastuzumab In Healthy Male Volunteers (REFLECTIONS B327-06)". 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 ...
What is the current status of trial NCT02015156?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 162 participants. The study started on 2014-01. Estimated completion is 2014-04.
What interventions are being tested in trial NCT02015156?
The interventions under investigation include: PF-05280014 (BIOLOGICAL), Herceptin® (BIOLOGICAL).
Who is sponsoring clinical trial NCT02015156?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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