A Safety and Pharmacokinetics Study in Participants With Rheumatoid Arthritis

Phase 1/2 Completed 121 enrolled Eli Lilly and Company

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to examine the safety and efficacy of this antibody in participants with rheumatoid arthritis. Part A of the study is an initial dose escalation phase Part B of the study is a randomized allocation of the entire dosing group to parallel treatment assignments

Timeline

Start: 2005-11
Primary completion: 2007-11
Completion: 2007-11

Publications

Bihorel S, Fiedler-Kelly J, Ludwig E, Sloan-Lancaster J, Raddad E. Population pharmacokinetic modeling of LY2189102 after multiple intravenous and subcutaneous administrations. AAPS J. 2014 Sep;16(5):1009-17. doi: 10.1208/s12248-014-9623-6. Epub 2014 Jun 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	LY2189102	Monoclonal antibody	0.02 mg/kg	Intravenous
Subject	LY2189102	Monoclonal antibody	0.1 mg/kg	Intravenous
Subject	LY2189102	Monoclonal antibody	0.15 mg/kg	Intravenous
Subject	LY2189102	Monoclonal antibody	0.3 mg/kg	Intravenous
Subject	LY2189102	Monoclonal antibody	1 mg/kg	Intravenous
Subject	LY2189102	Monoclonal antibody	2.5 mg/kg	Intravenous

A Safety and Pharmacokinetics Study in Participants With Rheumatoid Arthritis

Summary

Timeline

Publications

Drugs

Indications