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

Study Overview
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Brief Summary
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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.

Detailed Description
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The primary objective of this study is to characterize the safety, tolerability, and PK of GS-6624 after multiple IV administrations in patients with IPF. The secondary objectives are to evaluate the formation of anti-GS-6624 antibodies and to measure the effects of GS-6624 on FVC, DLCO, and SGRQ score. A total of 48 patients will be enrolled. In the double-blind phase (Part A), a total of 18 patients were enrolled at 3 dose levels. Part A was completed in October 2011. In Part B, 30 patients will be enrolled at 2 dose levels. Part B is open-label and is currently enrolling.

Official Title
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A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-6624 in Adult Subjects With Idiopathic Pulmonary Fibrosis

Conditions
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Idiopathic Pulmonary Fibrosis

Intervention / Treatment
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* Drug: GS-6624


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acceptable results on pulmonary function tests At rest oxygen saturation ≥90% on room air Adequate organ function Exclusion Criteria: High resolution computer tomography pattern showing emphysema that is greater than fibrosis Acceptable results on whole body plethysmography History of clinically significant hepatic or renal disease Poorly controlled or severe diabetes mellitus Use of systemic immunosuppressants within 28 days of GS-6624 infusion

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GS-6624 125mg<br> | Drug: GS-6624<br>* Patients will be treated with GS-6624 (125 or 200 mg) administered IV over 1 hour on specific days during the treatment period.<br>* Other names: AB0024;|
| Experimental: Experimental: GS-6624 200mg<br> | Drug: GS-6624<br>* Patients will be treated with GS-6624 (125 or 200 mg) administered IV over 1 hour on specific days during the treatment period.<br>* Other names: AB0024;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the safety, tolerability, and pharmacokinetics (PK) of GS-6624 | To characterize the safety, tolerability, and pharmacokinetics (PK) of GS-6624 after multiple intravenous (IV) administrations in subjects with idiopathic pulmonary fibrosis (IPF). | 113 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - To evaluate the formation of anti-GS-6624 antibodies. - To assess the effects of GS-6624 treatment on force vital capacity (FVC) and carbon dioxide diffusing capacity (DLCO) - To assess the effects of GS-6624 treatment on SGRQ | Secondary Endpoints: Anti-GS-6624 antibody formation; Change in FVC and DLCO; Change in SGRQ score. | 113 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibrosis, Pulmonary Fibrosis, Lung Diseases, Interstitial