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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 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 470 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02458209
The ClinicalTrials.gov registry entry for NCT02458209 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 470 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 3 interventions - of which bococizumab PFS:Pfizer is the first listed.
NCT02458209 reports 0 study locations.
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.
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