A Phase 2a Randomized, Doubled-Blind, Placebo-Controlled Trial to Evaluate Safety, Pharmacokinetics and Pharmacokinetic-Pharmacodynamic Relationships of RLS-0071 in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

RLS-0071-204

AECOPD is a major cause of hospital admission and mortality. They contribute to long-term decline in lung function, physical capacity, and quality of life (QoL). RLS-0071 is a novel peptide being developed for the treatment of AECOPD. This study is designed to evaluate the safety and tolerability of RLS-0071 in the treatment of adults with moderate exacerbations of COPD.

2024-01-25

2024-06-01

2024-06-01

Recruiting

Early phase I

24

Inclusion Criteria: * Hospitalized participants with a prior diagnosis of COPD including spirometry within the prior year documenting a postbronchodilator FEV1/FVC ≤ 0.7 and an FEV1 ≤ 80%, and a clinician identified admitting diagnosis of AECOPD: acute increase in dyspnea, sputum volume or purulence - without other attributable cause. * Participants must have a moderate exacerbation of COPD according to the Rome guidelines * ≥ 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 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 24, 'type': 'ESTIMATED'}}

2024-03-18