Trial intelligence / Profile preview

Bioequivalence of Denosumab CP4 vs CP2 in Healthy Volunteers

NCT02053753Phase 1Completed

Sponsor
Amgen
Start
Feb 2014
Primary completion
Aug 2014
Modality
Engineered Antibody Formats, Antibody Conjugates, Monoclonal Antibodies
Countries
1
01

Overview

Phase 1, randomised, double-blind trial of denosumab in bone metastases, Giant Cell Tumor of Bone (GCTB), multiple myeloma (MM) and 1 more (2 arms), sponsored by Amgen. Primary endpoints: Maximum Observed Drug Concentration at 127 days and Area Under the Drug Concentration-time Curve From Time 0 to 18 Weeks Post-dose. Started Feb 2014; status: completed.

02

Drugs

denosumab
03

Conditions

bone metastasesGiant Cell Tumor of Bone (GCTB)multiple myeloma (MM)hypercalcemia of malignancy (HCM)

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