Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02923791 · ClinicalTrials.gov registry record · Phase 1
A Study in Healthy Volunteers to Assess Immune Response to Multiple Injections of Filgrastim Hospira or Neupogen Reference Product.
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 256
- Enrollment target
NCT02923791 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 256 participants.
The verdict
NCT02923791, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 256 participants
- Enrollment target
Study Summary
This study compares the potential immunogenicity of two filgrastims, the proposed biosimilar Filgrastim Hospira (US) and the US-approved Neupogen reference product. Subjects will receive doses of one of the two filgrastims by injection of 5 micrograms/kilogram (mcg/kg). Subjects will receive 5 consecutive daily doses in Period 1 (Days 1-5) and a single dose on Day 1 of Period 2. Pre-dose and serial post-dose assessments of immunogenicity will be conducted each of the two study periods. In addition, safety assessments will be conducted throughout the study.
Interventions
- BIOLOGICAL Filgrastim Hospira
- BIOLOGICAL US-Approved Neupogen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 256 participants |
| Start Date | 2016-10 |
| Est. Completion | 2017-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02923791
The ClinicalTrials.gov registry entry for NCT02923791 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 256 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 Filgrastim Hospira is the first listed.
NCT02923791 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02923791 about?
NCT02923791 is a clinical study titled "A Study in Healthy Volunteers to Assess Immune Response to Multiple Injections of Filgrastim Hospira or Neupogen Reference Product.". This study compares the potential immunogenicity of two filgrastims, the proposed biosimilar Filgrastim Hospira (US) and the US-approved Neupogen reference product. Subjects will receive doses of one of the two filgrastims by injection of 5 micrograms/kilogram (mcg/kg). Subjects will receive 5 conse...
What is the current status of trial NCT02923791?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 256 participants. The study started on 2016-10. Estimated completion is 2017-01.
What interventions are being tested in trial NCT02923791?
The interventions under investigation include: Filgrastim Hospira (BIOLOGICAL), US-Approved Neupogen (BIOLOGICAL).
Who is sponsoring clinical trial NCT02923791?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.