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

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ReAlta Life Sciences, Inc.

Criteria

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