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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02053753 | Bioequivalence Study of Denosumab CP4 Drug Product and Commercially Available Denosumab CP2 Drug Product | PHASE1 | COMPLETED | 146 | — | — | Feb 1, 2014 | Aug 1, 2014 | Dec 29, 2017 | 2 | United States |
Serum denosumab concentration-time data were analyzed by non-compartmental methods. Serum concentrations below the LLOQ (20.0 ng/mL) were set to 0 before data analysis.
Serum denosumab concentration-time data were analyzed by non-compartmental methods. Serum concentrations below the LLOQ (20.0 ng/mL) were set to 0 before data analysis.
| Arm | Type | Description |
|---|---|---|
| Drug Product CP4 | EXPERIMENTAL | Participants received a single dose of 120 mg denosumab manufactured using the new CP4 process subcutaneously on day 1. |
| Drug Product CP2 | EXPERIMENTAL | Participants received a single dose of 120 mg denosumab manufactured using the current CP2 process subcutaneously on day 1. |
| Name | Type | Description |
|---|---|---|
| Denosumab CP4 | DRUG | Denosumab produced by a process referred to as CP4, administered subcutaneously. |
| Denosumab CP2 | DRUG | Denosumab produced by a process referred to as CP2, administered subcutaneously. |
Key Inclusion: * Healthy male and female, ages ≥ 18 to ≤ 65 years (inclusive) * Body weight \> 60 to \< 100 kg at time of screening * Clinically acceptable physical exams and laboratory tests (blood hematology, blood chemistry, urinalysis) and no history or evidence of any clinically significant me...