A Study to Evaluate the Safety and Efficacy of GS-6624 (Formerly AB0024) in Patients With Idiopathic Pulmonary Fibrosis
Status: | Completed |
---|---|
Conditions: | Pulmonary |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 40 - 85 |
Updated: | 4/21/2016 |
Start Date: | December 2010 |
End Date: | December 2012 |
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-6624 in Adult Subjects With Idiopathic Pulmonary Fibrosis
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.
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.
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.
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.
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
We found this trial at
7
sites
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000

Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414

Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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10833 Le Conte Ave
Los Angeles, California 90095
Los Angeles, California 90095
(310) 825-4321

David Geffen School of Medicine, UCLA In 2002 Mr. David Geffen announced a $200 million...
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Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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