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 small molecule being studied in healthy volunteers. It is being evaluated in a Phase 1 bioequivalence study to compare it with a commercially available denosumab product. The drug is not approved and remains in clinical development.
Denosumab CP4 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The company is conducting clinical trials to evaluate the drug's bioequivalence to an existing denosumab product.
Denosumab CP4 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 study has been completed, and the drug is not currently in active clinical trials.
Denosumab CP4 has one completed clinical trial, NCT02053753, titled "Bioequivalence Study of Denosumab CP4 Drug Product and Commercially Available Denosumab CP2 Drug Product." This Phase 1 study enrolled 146 healthy volunteers in the United States and was randomized, double-blind, and controlled.
Denosumab CP4 is a drug product being studied for bioequivalence to a commercially available denosumab product, referred to as Denosumab CP2. The study compares the two formulations to determine if they are equivalent, but Denosumab CP4 itself is an investigational product.