Single Dose Manufacturing Site (Pfizer vs. BIP) And Device (Prefilled Syringe vs. Prefilled Pen) Comparability Study For Bococizumab In Healthy Volunteers
Public ClinicalTrials.gov record NCT02458209. 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 1, Open-label, Randomized, Single Dose, Parallel Group Comparability Study To Assess The Subcutaneous Pharmacokinetics And Pharmacodynamics Of Bococizumab In Healthy Adult Subjects For Comparisons Of Drug Substance Manufactured At Two Different Locations And Administration Via Prefilled Syringe Vs. Prefilled Pen
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is an open label, single dose, randomized, parallel group study in healthy adult subjects to assess the comparability of bococizumab administered in a prefilled syringe vs. prefilled pen and comparability between drug substance manufactured at Pfizer Andover vs. Boehringer Ingelheim Pharma.
Study identification
- NCT ID
- NCT02458209
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 470 participants
Conditions and interventions
Conditions
Interventions
- bococizumab PFS:Pfizer Biological
- bococizumab PFS: BIP Biological
- bococizumab PFP Biological
Biological
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
- Apr 30, 2015
- Primary completion
- Nov 30, 2015
- Completion
- Nov 30, 2015
- Last update posted
- Mar 7, 2016
2015
United States locations
- U.S. sites
- 5
- U.S. states
- 3
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Broward Research Group | Hollywood | Florida | 33024 | — |
| Miami Research Associates, LLC | South Miami | Florida | 33143 | — |
| MRA Clinical Research, LLC | South Miami | Florida | 33143 | — |
| Prism Research, LLC | Saint Paul | Minnesota | 55114 | — |
| High Point Clinical Trials Center, LLC | High Point | North Carolina | 27265 | — |
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 NCT02458209, 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 Mar 7, 2016 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02458209 live on ClinicalTrials.gov.