A Study in Healthy Volunteers to Assess Immune Response to Multiple Injections of Filgrastim Hospira or Neupogen Reference Product.
Public ClinicalTrials.gov record NCT02923791. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase I, Randomized Open-label, 2-period, Parallel Arm Study To Assess The Immunogenicity Of Multiple Subcutaneous (SC) Doses Of "Filgrastim Hospira" (US) Or US-approved Neupogen(Registered) Reference Product In Healthy Volunteers
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02923791
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 256 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 2016 (Type not available)
- Primary completion
- Jan 2017 (Actual)
- Completion
- Jan 2017 (Actual)
- Last update posted
- Feb 23, 2017
2016 – 2017
United States locations
- U.S. sites
- 3
- U.S. states
- 1
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| SeaView Research, Inc. | Coral Gables | Florida | 33134 | — |
| Seaview Jacksonville LLC | Jacksonville | Florida | 32256 | — |
| SeaView Research, Inc. | Miami | Florida | 33126 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02923791, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 23, 2017 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02923791 live on ClinicalTrials.gov.