Safety, Tolerability, and Pharmacokinetics of GS-5745 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Inclusion Criteria:

- Weight: ≥ 45 kg to < 120 kg at screening

- Males or non-pregnant, non-lactating females

- Male subjects and female subjects of childbearing potential who engage in
heterosexual intercourse must agree to use protocol specified method(s) of
contraception. Male subjects must refrain from sperm donation for 90 days post last
infusion of the study drug

- Diagnosis of COPD per Global Initiative for Chronic Obstructive Lung Disease (GOLD)
guidelines for at least 6 months prior to screening and anticipated to remain on
stable therapy for the duration of the study

- Post-bronchodilator forced expiratory volume in one second (FEV1) ≥ 40% predicted

- No changes in COPD medications within 30 days prior to randomization

- Hepatic panel [aspartate aminotransferase (AST), alanine aminotransferase (ALT),
total bilirubin, direct bilirubin, alkaline phosphatase, lactate dehydrogenase (LDH)]
≤ 2 times the upper limit of the normal range (ULN)

- Serum creatinine ≤ 2.0

- Hemoglobin ≥ 8.5 g/dL (both males and females)

- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (1,500 mm^3)

- Platelets ≥ 100 x 10^9/L

Exclusion Criteria:

- Clinically significant active infection as judged by the investigator during
screening

- Known history of HIV, hepatitis B or C during screening. Subjects who are hepatitis B
surface antigen positive, but who received a successful series of hepatitis B
vaccinations and never had the disease remain eligible

- A positive QuantiFERON-TB GOLD test during screening

- History of malignancy within the last 5 years except for patients who have been
treated locally for non-melanoma skin cancer or cervical carcinoma in situ

- Any serious cardiac event such as myocardial infarction, unstable or life-threatening
arrhythmia, hospitalization for cardiac failure within 6 months prior to
randomization or any significant or new electrocardiogram (ECG) finding at Visit 1 as
judged by the Investigator

- A hospitalization for a respiratory event such as, but not limited to, COPD,
pneumonia, bronchiolitis, within the previous 6 months prior to randomization

- Chronic lung disease other than COPD such as: asthma, cystic fibrosis or fibrotic
disease, α-1-antitrypsin deficiency, interstitial lung disease, pulmonary
thromboembolic disease, or bronchiectasis

- Chronic use of systemic corticosteroids and/or treatment with systemic
corticosteroids for an acute exacerbation of COPD (AECOPD) event, or other medical
condition not requiring hospitalization, within 90 days of randomization.

- Treatment with antibiotics for an AECOPD event, or other medical condition not
requiring hospitalization within 90 days of randomization, or any minor medical event
not requiring hospitalization within 14 days of randomization.

- Treatment with any marketed or investigational biologic within 5 half-lives of the
molecule or if unknown within 90 days of screening

- Subjects currently on nonbiologic immune modulator medications such as: azathioprine,
cyclosporine, hydroxychloroquine, leflunomide, methotrexate, mycophenolate mofetil,
sulfasalazine, tofacitinib, within 90 days of randomization