NCT06175065

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: ReAlta Life Sciences, Inc. · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized, double-blind, placebo controlled trial in hospitalized participants with Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD) to evaluate the safety, tolerability, preliminary efficacy, PK, and PD of RLS-0071 compared to Placebo in the treatment of AECOPD. The dosing regimen will be 3 times a day for at least 3 days and up to 5 days total if still hospitalized. Participants will be followed for efficacy and safety for 30 and 60 days after the final dose. RLS-0071 or Placebo will be given as add-on therapy to SOC management for acute exacerbations of COPD.

Conditions

• Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	RLS-0071	RLS-0071, will be administered as an IV infusion 10 mg/kg. Planned infusion duration is 8 minutes.
DRUG	Placebo	Placebo control (commercial sterile saline), will be administered as an IV infusion. Planned infusion duration is 8 minutes.

Timeline

• Start date: 2024-01-25
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2023-12-18
• Last updated: 2025-05-08

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study