NCT02171143

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

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP2409 Following a Single Intravenous Dose in Patients With Rheumatoid Arthritis on Methotrexate

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a dose-escalation study. Sequential cohorts of subjects will receive increasing doses of ASP2409 or matching placebo. Subjects in all cohorts will stay confined in the unit for 3 days. All subjects will have scheduled outpatient visits and be followed for a minimum of 90 days.

Conditions

• Rheumatoid Arthritis
• Pharmacokinetics of ASP2409

Interventions

Type	Name	Description
DRUG	ASP2409	intravenous (IV)
DRUG	Placebo	intravenous (IV)

Timeline

• Start date: 2012-04-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2014-06-24
• Last updated: 2014-06-24

Locations

10 sites across 1 country: United States