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 being studied in healthy volunteers. It is not approved for any disease and is in Phase 1 clinical development. The only completed trial evaluated the drug in healthy participants to compare manufacturing sites and delivery devices.
Bococizumab is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. The company sponsored the Phase 1 clinical trial of this investigational monoclonal antibody.
Bococizumab is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and no active trials are currently listed.
Bococizumab has one completed Phase 1 trial, NCT02458209, titled "Single Dose Manufacturing Site (Pfizer vs. BIP) And Device (Prefilled Syringe vs. Prefilled Pen) Comparability Study For Bococizumab In Healthy Volunteers." The trial enrolled 470 healthy participants in the United States.
Bococizumab is not FDA approved. It is an investigational monoclonal antibody in Phase 1 clinical development. The drug has only been studied in healthy volunteers, and no approval status has been established.