drugset / Trial / NCT01059435

A First-in-human Study Evaluating Romosozumab (AMG 785) in Healthy Men and Postmenopausal Women

NCT01059435

Phase 1 Completed 74 enrolled Amgen
RandomizedSequentialDouble-blindTreatment

Summary

The primary objective of this study is to assess the safety and tolerability of romosozumab following single dose subcutaneous (SC) or intravenous (IV) administration in healthy men and postmenopausal women.

Timeline

Start
2006-12-13
Primary completion
2007-07-06
Completion
2007-07-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Romosozumab Monoclonal antibody 0.1 mg/kg Subcutaneous
Subject Romosozumab Monoclonal antibody 10 mg/kg Subcutaneous

Indications