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Safety, PK and PD Relationships of RLS-0071 in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Sponsor: ReAlta Life Sciences, Inc.
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.
Official title: 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
Key Details
Gender
All
Age Range
30 Years - Any
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2024-01-25
Completion Date
2025-06
Last Updated
2025-05-08
Healthy Volunteers
No
Interventions
RLS-0071
RLS-0071, will be administered as an IV infusion 10 mg/kg. Planned infusion duration is 8 minutes.
Placebo
Placebo control (commercial sterile saline), will be administered as an IV infusion. Planned infusion duration is 8 minutes.
Locations (4)
Site 02
St. Petersburg, Florida, United States
Site 03
Glen Burnie, Maryland, United States
Site 04
Omaha, Nebraska, United States
Site 01
Philadelphia, Pennsylvania, United States