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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: Completed Phase 1 study, sponsored by Pfizer.
NCT02923791 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 256 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (327% higher). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT02923791 record still lists
NCT02923791 is an interventional study that assigns participants to a tested intervention. The registered 256 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (327% higher).
The record links to 0 conditions, and to 2 interventions - of which Filgrastim Hospira is the first listed.
NCT02923791 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT02923791's enrollment target sits among peer trials
256 168th of 2000 higher than 1,833 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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