The primary objective of this study is to evaluate the effect of andecaliximab (GS-5745) on pre-bronchodilator forced expiratory volume in 1 second (FEV1) % predicted in adults with cystic fibrosis (CF) after 8 weeks of treatment. There will be 2 parts to this study. In Part 1, andecaliximab 600 mg or placebo will be administered for 8 weeks. In Part 2, andecaliximab 300 mg, 150 mg, or placebo will be administered for 8 weeks. Part 2 will be initiated after completion of Part 1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
6
Administered via subcutaneous injection
Administered via subcutaneous injection
Unnamed facility
New Lambton, New South Wales, Australia
Unnamed facility
Montpellier, France
Unnamed facility
Berlin, Germany
Unnamed facility
Barcelona, Spain
Unnamed facility
Liverpool, United Kingdom
Absolute Change in Pre-bronchodilator FEV1 Percent Predicted From Baseline to Week 8
Time frame: Baseline; Week 8
Absolute Change in Post-bronchodilator FEV1 Percent Predicted From Baseline to Week 8
Time frame: Baseline; Week 8
Relative Change in Pre-bronchodilator FEV1 Percent Predicted From Baseline to Week 8
Time frame: Baseline; Week 8
Relative Change in Post-bronchodilator FEV1 Percent Predicted From Baseline to Week 8
Time frame: Baseline; Week 8
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