drugset

drugset / Trial / NCT03822078

Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Denosumab (AMG 162) in Japanese Postmenopausal Women

NCT03822078 ↗

Phase 1 Completed 45 enrolled Amgen

RandomizedSequentialTriple-blindTreatment

Summary

The primary objective was to evaluate the safety and tolerability of denosumab (AMG 162) after a single subcutaneous administration in Japanese postmenopausal women.

Timeline

Start: 2003-09-30
Primary completion: 2004-12-24
Completion: 2004-12-24

Publications

Background Kumagai Y, Hasunuma T, Padhi D. A randomized, double-blind, placebo-controlled, single-dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of denosumab administered subcutaneously to postmenopausal Japanese women. Bone. 2011 Nov;49(5):1101-7. doi: 10.1016/j.bone.2011.08.007. Epub 2011 Aug 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Denosumab	Monoclonal antibody	0.03 mg/kg	Subcutaneous
Subject	Denosumab	Monoclonal antibody	0.1 mg/kg	Subcutaneous
Subject	Denosumab	Monoclonal antibody	0.3 mg/kg	Subcutaneous
Subject	Denosumab	Monoclonal antibody	1 mg/kg	Subcutaneous
Subject	Denosumab	Monoclonal antibody	3 mg/kg	Subcutaneous

Indications