drugset / Trial / NCT01101061

A Single-dose Study Evaluating Romosozumab (AMG 785) in Healthy Postmenopausal Japanese and Non-Japanese Women

NCT01101061

Phase 1 Completed 31 enrolled Amgen
RandomizedSequentialDouble-blindTreatment

Summary

The main purpose of this study is to assess the safety, tolerability and potential immune response to romosozumab following single subcutaneous (SC; injection under the skin) dose administration in healthy postmenopausal Japanese and non-Japanese women.

Timeline

Start
2010-05-03
Primary completion
2010-11-01
Completion
2010-11-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Romosozumab Monoclonal antibody 1 mg/kg Subcutaneous
Subject Romosozumab Monoclonal antibody 3 mg/kg Subcutaneous
Subject Romosozumab Monoclonal antibody 5 mg/kg Subcutaneous

Indications

No indication recorded.