Safety, PK and PD Relationships of RLS-0071 in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Inclusion Criteria:

• Hospitalized participants with a prior diagnosis of COPD including spirometry withinthe prior year documenting a postbronchodilator FEV1/FVC ≤ 0.7 and an FEV1

≤ 80%, and a clinician identified admitting diagnosis of AECOPD: acute increase indyspnea, sputum volume or purulence - without other attributable cause.

• Participants must have a moderate exacerbation of COPD according to the Romeguidelines

• ≥ 10 pack-years smoking history.

Exclusion Criteria:

• Endotracheal intubation or mechanical ventilation.

• Participants with severe exacerbation of COPD according to the Rome guidelines

• Participants with signs and symptoms consistent with an alternative diagnosis forworsening of pulmonary status

• Interstitial lung disease.

• Current or prior history of asthma.

• Known hypersensitivity, allergy, or reaction to polyethylene glycol (PEG)

• Preexisting autoimmune disease: History of autoimmune disease and/or use of chronicsteroids of >10mg/d (prednisone or equivalent) for more than 14 days prior toenrollment

• Current renal dialysis or renal dialysis planned or anticipated in the next 7 days.

• Has confounding medical conditions, including:

1. diabetic coma,

2. uncontrolled New York Heart Association Class IV congestive heart failure,

3. uncontrolled angina,

4. stroke or transient ischemic attack (TIA) within 4 weeks before study entry,

5. clinically significant arrhythmias not controlled by medication, or

6. idiopathic pulmonary fibrosis,

• Has a weight >120 kg at Screening.

• Known pregnancy, a positive pregnancy test at screening, or lactation for WOCBP.

• Has systemic immunosuppression/immune deficiency