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

NCT06175065 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: RLS-0071-204
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

  Day 1 to Day 60

Secondary Outcomes (15)

• Time to reach maximum observed serum concentration (Tmax) for RLS-0071

  Day 1 and Day 3

• Maximum Observed Serum Concentration (Cmax) for RLS-0071

  Day 1 and Day 3

• Area Under the Curve From Time 0 to Infinity (AUC [0 - infinity]) for RLS-0071

  Day 1 and Day 3

• Terminal Phase Elimination Half-Life (t1/2) for RLS-0071

  Day 1 and Day 3

• Evaluate the change in plasma neutrophil counts from Day 0 up to Day 5.

  Day 0 up to Day 5.

Study Arms (2)

RLS-0071

EXPERIMENTAL

Doses of RLS-0071, will be administered Q8H, three times a day, for at least 3 days and up to 5 days

Drug: RLS-0071

Placebo

PLACEBO COMPARATOR

Doses of Placebo for RLS-0071, will be administered Q8H, three times a day, for at least 3 days and up to 5 days

Drug: Placebo

Interventions

RLS-0071 DRUG

RLS-0071, will be administered as an IV infusion 10 mg/kg. Planned infusion duration is 8 minutes.

RLS-0071

Placebo DRUG

Placebo control (commercial sterile saline), will be administered as an IV infusion. Planned infusion duration is 8 minutes.

Placebo

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• diabetic coma,
• uncontrolled New York Heart Association Class IV congestive heart failure,
• uncontrolled angina,
• stroke or transient ischemic attack (TIA) within 4 weeks before study entry,
• clinically significant arrhythmias not controlled by medication, or
• idiopathic pulmonary fibrosis,

Sponsors & Collaborators

• ReAlta Life Sciences, Inc.: lead

Study Sites (4)

Site 02

St. Petersburg, Florida, 33701, United States

Location

Site 03

Glen Burnie, Maryland, 21061, United States

Location

Site 04

Omaha, Nebraska, 68198, United States

Location

Site 01

Philadelphia, Pennsylvania, 19122, United States

Location

MeSH Terms

Interventions

RLS-0071

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 18, 2023
• Study Start: January 25, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: May 8, 2025

Record last verified: 2025-05

Locations

US (4)