Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
bococizumab PFS:Pfizer · 1 trial · 1 indication
maximal plasma concentration
area under the concentration time curve from time 0 extrapolated to infinite time (AUCinf)
Cmax of bococizumab using drug substance (DS) manufactured by Pfizer vs. DS manufactured by BIP
Cmax of bococizumab using drug substance (DS) manufactured by Pfizer vs. DS manufactured by BIP
Cmax of bococizumab administered via prefilled syringe vs. a prefilled pen
AUcinf of bococizumab administered via prefilled syringe vs. a prefilled pen
| Arm | Type | Description |
|---|---|---|
| Treatment A | ACTIVE_COMPARATOR | 150 mg SC dose administered in a prefilled syringe using drug substance manufactured at Pfizer Andover |
| Treatment B | EXPERIMENTAL | • Treatment B: 150 mg SC dose administered in a prefilled syringe using drug substance manufactured at Boehringer Ingelheim Pharma |
| Treatment C | EXPERIMENTAL | 150 mg SC dose administered in a prefilled pen using drug substance manufactured at Pfizer Andover. |
| Name | Type | Description |
|---|---|---|
| bococizumab PFS:Pfizer | BIOLOGICAL | 150 mg bococizumab administered SC in a prefilled syringe using drug substance manufactured at Pfizer Andover |
| bococizumab PFS: BIP | BIOLOGICAL | 150 mg bococizumab administered SC in a prefilled syringe using drug substance manufactured at Boehringer Ingelheim Pharma. |
| bococizumab PFP | BIOLOGICAL | 150 mg bococizumab administered SC in a prefilled pen using drug substance manufactured at Pfizer Andover |
Inclusion Criteria: 1. Healthy male and/or female subjects between the ages of 18 and 65 years 2. Body Mass Index (BMI) 33.0 kg/m2 or lower; and a total body weight 60 to 90 kg (132 198 lbs) inclusive 3. Fasting LDL-C must be 80 to 200 mg/dL at two qualifying visits: initial screening (Days -28 to ...
Bococizumab is an investigational monoclonal antibody developed by Pfizer, Inc. (NYSE: PFE) that targets PCSK9. It is not approved for any indication and remains in clinical development. The program includes a Phase 1 study in healthy volunteers, and no approved uses or commercial availability have been established.
Bococizumab targets PCSK9, proprotein convertase subtilisin/kexin type 9. It is a monoclonal antibody that acts as a PCSK9 inhibitor. By binding PCSK9, the antibody is designed to interfere with PCSK9-mediated regulation of LDL receptor activity, a mechanism relevant to cholesterol handling.
Bococizumab is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the sponsor of the clinical program for bococizumab, including the Phase 1 comparability study conducted in the United States.
Bococizumab is in Phase 1 clinical development. It is an investigational monoclonal antibody and is not FDA approved. The program includes one completed Phase 1 trial, and no later-phase trials are listed. The Phase 1 study enrolled 470 healthy volunteers.
Bococizumab has been studied in one completed Phase 1 trial, NCT02458209. The trial was a single-dose manufacturing site and device comparability study for bococizumab in healthy volunteers, comparing Pfizer versus BIP manufacturing sites and prefilled syringe versus prefilled pen devices. It enrolled 470 participants in the United States.