drugset / Trial / NCT01825785

A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Romosozumab (AMG 785)

NCT01825785

Phase 1 Completed 48 enrolled Amgen
RandomizedSequentialDouble-blindTreatment

Summary

The primary objective of this study was to assess the safety, tolerability, and immunogenicity potential of romosozumab following multiple subcutaneous (SC) administrations in healthy men and postmenopausal women with low bone mass.

Timeline

Start
2007-11-14
Primary completion
2008-12-02
Completion
2008-12-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Romosozumab Monoclonal antibody 1 mg/kg Subcutaneous
Subject Romosozumab Monoclonal antibody 2 mg/kg Subcutaneous
Subject Romosozumab Monoclonal antibody 3 mg/kg Subcutaneous

Indications

No indication recorded.