NCT02176876

Safety, Tolerability, and Pharmacokinetics of GS-5745 in Subjects With Rheumatoid Arthritis

A Phase 1b, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GS-5745 in Subjects With Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is to assess the safety, tolerability, and pharmacokinetics (PK) of multiple infusions of GS-5745 in adults with rheumatoid arthritis (RA). Participants will be randomized in a 4:1 ratio to receive 1 intravenous (IV) infusion of GS-5745 or placebo every 2 weeks, for a total of 3 IV infusions.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	GS-5745	GS-5745 400 mg administered intravenously
DRUG	Placebo to match GS-5745	Placebo to match GS-5745 administered intravenously

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-04-01
• Completion: 2015-06-01
• First posted: 2014-06-27
• Last updated: 2015-06-29

Locations

4 sites across 2 countries: Czechia, Hungary