Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02458209 | Single Dose Manufacturing Site (Pfizer vs. BIP) And Device (Prefilled Syringe vs. Prefilled Pen) Comparability Study For Bococizumab In Healthy Volunteers | PHASE1 | COMPLETED | 470 | — | — | May 1, 2015 | Dec 1, 2015 | Mar 8, 2016 | 5 | United States |
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 ...