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. It was studied in healthy adult volunteers in a Phase 1 comparability trial, not in patients with a disease indication. It is not an approved medicine and remains an investigational agent in clinical development.
Bococizumab targets PCSK9, proprotein convertase subtilisin/kexin type 9. It is a monoclonal antibody that acts as an inhibitor of PCSK9. Targeting PCSK9 is a mechanism intended to affect cholesterol handling, though the trial described here was conducted in healthy volunteers rather than a patient population.
Bococizumab is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the Phase 1 comparability study of the drug in healthy volunteers.
Bococizumab is in Phase 1 development. It is investigational and has not been approved by the FDA. The only listed trial is a completed Phase 1 study, and there are no active trials of bococizumab recorded.
Bococizumab has been studied in one completed Phase 1 trial, NCT02458209, titled a single dose manufacturing site and device comparability study for bococizumab in healthy volunteers. It enrolled 470 participants in the United States, was randomized and active controlled, and included adults 18 years and older of any sex.