Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Denosumab CP4 · 1 trial · 1 indication
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...
Denosumab CP4 is an investigational monoclonal antibody developed by Amgen Inc. (ticker AMGN). It is a Phase 1 candidate studied in healthy volunteers, and its intended therapeutic indications have not been disclosed. It is a distinct drug product from the commercially available denosumab product referenced as CP2 in its bioequivalence study.
Denosumab CP4 targets TNFSF11, also known as RANK ligand, and acts as an inhibitor of that target. TNFSF11 is a cytokine involved in the regulation of bone resorption. By binding and inhibiting TNFSF11, the antibody is designed to block signaling through its receptor. Denosumab CP4 is a monoclonal antibody modality.
Amgen Inc., which trades under the ticker AMGN, is the developer of Denosumab CP4. Amgen is also the sponsor of the clinical study conducted for this asset. The drug is an investigational monoclonal antibody candidate and has not been described as partnered or licensed to another company.
Denosumab CP4 is in Phase 1 development. Its only recorded clinical trial was a Phase 1 bioequivalence study that has been completed. The drug is investigational and is not described as approved by the FDA for any indication. No active trials for Denosumab CP4 are currently listed.
Denosumab CP4 has been studied in one completed Phase 1 trial, NCT02053753, titled Bioequivalence Study of Denosumab CP4 Drug Product and Commercially Available Denosumab CP2 Drug Product. The trial enrolled 146 healthy volunteers in the United States, was randomized, double blind, and controlled, and included participants aged 18 years and older.
Denosumab CP4 is a specific drug product evaluated against a commercially available denosumab product referred to as CP2 in a bioequivalence study. The trial compared the two products in healthy volunteers. Denosumab CP4 is an investigational Phase 1 monoclonal antibody developed by Amgen, while CP2 is the commercially available comparator product.