A Study to Evaluate the Safety and Efficacy of GS-6624 (Formerly AB0024) in Patients With Idiopathic Pulmonary Fibrosis

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The study consists of 2 parts: Part A is a randomized, multiple-dose, double-blind, placebo-controlled sequential dose escalation study to evaluate GS-6624 in subjects with Idiopathic Pulmonary Fibrosis (IPF) and was completed in October 2011.

Part B is a randomized, two-dose, open-label dose expansion study to evaluate GS-6624 in subjects with IPF and is currently enrolling.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences

Criteria

Inclusion Criteria:

1. Acceptable results on pulmonary function tests

2. At rest oxygen saturation ≥90% on room air

3. Adequate organ function

Exclusion Criteria:

1. High resolution computer tomography pattern showing emphysema that is greater than fibrosis

2. Acceptable results on whole body plethysmography

3. History of clinically significant hepatic or renal disease

4. Poorly controlled or severe diabetes mellitus

5. Use of systemic immunosuppressants within 28 days of GS-6624 infusion