A Dose Escalation Study to Assess Safety, Tolerability and Pharmacokinetics of ASP2409 Following a Single Intravenous Dose in Patients With Rheumatoid Arthritis on Methotrexate

Summary

The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of single, ascending, intravenous (IV) doses of ASP2409 in patients with Rheumatoid Arthritis (RA) on methotrexate (MTX) and to evaluate the pharmacodynamics (PD) of ASP2409.

Timeline

Start

2012-04

Primary completion

2014-04

Completion

2014-04

Publications

• Zhang W, Kernstock RM, Karrer EE, Cohen SB, Chindalore VL, Kivitz AJ, Blahunka PC, Delgado-Herrera L, Zeiher BG, Samberg NL, Garg JP. A Phase 1 Dose-Escalation Study of ASP2409, a Selective T-Cell Costimulation Inhibitor, in Stable Rheumatoid Arthritis Patients on Methotrexate Therapy. Clin Pharmacol Drug Dev. 2016 Jul;5(4):259-68. doi: 10.1002/cpdd.237. Epub 2016 Jan 8.

Drugs

Indications