RecruitingPhase 1Phase 2NCT06603246

A Study to Test the Safety and Effects of Inhaled GDC-6988 in Participants With Muco-obstructive Disease

A Phase Ic, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, and Activity of Inhaled GDC-6988 in Patients With Muco-obstructive Disease


Sponsor

Genentech, Inc.

Enrollment

128 participants

Start Date

Nov 18, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study evaluates the safety, tolerability, and activity of inhaled GDC-6988 in participants with muco-obstructive disease.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether an inhaled drug called GDC-6988 is safe and effective for people with muco-obstructive lung diseases — conditions where thick, sticky mucus blocks the airways — including bronchiectasis (non-cystic fibrosis type) and COPD with chronic bronchitis. **You may be eligible if...** - Your lung function (FEV1) is at least 40% of predicted normal - You have been on a stable treatment regimen for your lung condition for at least 28 days - Your condition has been stable for at least 28 days before screening - You are able to correctly use the inhaled device used in the study - If in certain study groups: you produce daily sputum and have bronchiectasis involving at least 2 lung lobes, OR you have COPD with chronic bronchitis **You may NOT be eligible if...** - Your lung function is too severely impaired (FEV1 below 40%) - Your condition has not been stable recently - You are unable to use the inhaler device correctly Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGDC-6988

GDC-6988 will be administered using a dry powder inhalation (DPI) device.


Locations(7)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Accel Research Site - Achieve - Birmingham - ERN - PPDS

Vestavia Hills, Alabama, United States

Stanford Center for Excellence in Pulmonary Biology

Palo Alto, California, United States

University of Kansas Medical Center-Kansas City-3901 Rainbow Blvd

Kansas City, Kansas, United States

University of North Carolina Clinical Research Center

Chapel Hill, North Carolina, United States

UPMC Montefiore Hospital

Pittsburgh, Pennsylvania, United States

TTS Research

Boerne, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06603246


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