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NCT02458209 · ClinicalTrials.gov registry record · Phase 1
Single Dose Manufacturing Site (Pfizer vs. BIP) And Device (Prefilled Syringe vs. Prefilled Pen) Comparability Study For Bococizumab In Healthy Volunteers
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 470
- Enrollment target
NCT02458209: Completed Phase 1 study, sponsored by Pfizer.
NCT02458209 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 470 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (683% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02458209, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 470 participants
- Enrollment target
Study Summary
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.
Primary Outcome
maximal plasma concentration
Interventions
- BIOLOGICAL bococizumab PFS:Pfizer
- BIOLOGICAL bococizumab PFS: BIP
- BIOLOGICAL bococizumab PFP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 470 participants |
| Start Date | 2015-05 |
| Est. Completion | 2015-12 |
| Phase | Phase 1 |
What the finished NCT02458209 record still lists
NCT02458209 is an interventional study that assigns participants to a tested intervention. The registered 470 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 (683% higher).
The record links to 0 conditions, and to 3 interventions - of which bococizumab PFS:Pfizer is the first listed.
NCT02458209 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02458209 about?
NCT02458209 is a clinical study titled "Single Dose Manufacturing Site (Pfizer vs. BIP) And Device (Prefilled Syringe vs. Prefilled Pen) Comparability Study For Bococizumab In Healthy Volunteers". 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.
What is the current status of trial NCT02458209?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 470 participants. The study started on 2015-05. Estimated completion is 2015-12.
What interventions are being tested in trial NCT02458209?
The interventions under investigation include: bococizumab PFS:Pfizer (BIOLOGICAL), bococizumab PFS: BIP (BIOLOGICAL), bococizumab PFP (BIOLOGICAL).
Who is sponsoring clinical trial NCT02458209?
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 NCT02458209's enrollment target sits among peer trials
470 52nd of 2000 higher than 1,949 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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