NCT02698657

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP5094 Following Multiple Intravenous Doses in Subjects With Rheumatoid Arthritis on Methotrexate

A Phase 1, Randomized, Placebo-controlled, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP5094 Following Multiple Intravenous Doses in Subjects With Rheumatoid Arthritis on Methotrexate

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of multiple ascending intravenous doses of ASP5094 in male and female subjects with rheumatoid arthritis (RA) on methotrexate (MTX).

Conditions

• Rheumatoid Arthritis (RA)

Interventions

Type	Name	Description
DRUG	ASP5094	Intravenous (IV)
DRUG	Placebo	Intravenous (IV)

Timeline

• Start date: 2016-02-23
• Primary completion: 2017-09-07
• Completion: 2017-09-07
• First posted: 2016-03-04
• Last updated: 2024-10-31

Locations

13 sites across 2 countries: United States, Poland