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ACTIVE NOT RECRUITING
NCT06175065
PHASE2

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

Sponsor: ReAlta Life Sciences, Inc.

View on ClinicalTrials.gov

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

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.

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