NCT02077465

Safety, Tolerability, and Pharmacokinetics of Andecaliximab in Adults With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 1 Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GS-5745 in Subjects With Chronic Obstructive Pulmonary Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to assess the safety and tolerability of multiple infusions of andecaliximab (formerly GS-5745) in participants with chronic obstructive pulmonary disease (COPD) as assessed by adverse events (AEs) and laboratory abnormalities.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Andecaliximab	400 mg andecaliximab administered intravenously
DRUG	Placebo to match Andecaliximab	Placebo to match andecaliximab administered intravenously

Timeline

• Start date: 2014-03-11
• Primary completion: 2014-10-27
• Completion: 2014-10-27
• First posted: 2014-03-04
• Last updated: 2020-09-09
• Results posted: 2020-08-13

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study