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

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 for worsening 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 chronic steroids of \>10mg/d (prednisone or equivalent) for more than 14 days prior to enrollment
• •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