What is GDC-6988 studying for muco-obstructive diseases?

GDC-6988 is being studied to evaluate its safety, tolerability, and effects in people with muco-obstructive diseases like non-cystic fibrosis bronchiectasis and COPD. The research aims to understand how this inhaled treatment impacts lung function and mucus properties. Genentech, Inc. is leading this clinical trial to explore new treatment options.

Who may be eligible for this muco-obstructive disease clinical trial?

Adults aged 18 years and older with a diagnosis of non-cystic fibrosis bronchiectasis or chronic obstructive pulmonary disease may be eligible. Participants need stable lung function and treatment for at least 28 days and should not be pregnant or breastfeeding. Please review eligibility criteria for more details.

Is there any cost to participate in this muco-obstructive disease clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered during participation.

Actively Recruiting

Phase 1

Age: 18Years +

All Genders

ID06603246

Phase 1 Study to Assess Safety and Effects of Inhaled GDC-6988 in Adults With Muco-obstructive Lung Diseases

Led by Genentech, Inc. · Updated on 2026-08-04

128

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety, tolerability, and activity of an inhaled drug called GDC-6988 in adults with muco-obstructive diseases, including non-cystic fibrosis bronchiectasis and chronic obstructive pulmonary disease COPD. This Phase 1 clinical trial aims to understand how this inhaled treatment affects lung function and respiratory symptoms in these patients. Participants receive GDC-6988 using a dry powder inhalation device. Different groups receive varying doses and schedules one group receives a low dose followed by a high dose on the first two days, another group receives both doses twice daily for 14 days, and other groups receive low dose twice daily for 14 days. The study is open-label and conducted at multiple centers. During the study, participants undergo lung function tests, including spirometry, and provide sputum and blood samples for biomarker analysis. Researchers monitor adverse events and lung function changes for up to 6 weeks after treatment starts. They also assess changes in mucus properties and lung clearance using specialized imaging. The trial involves repeated assessments over 14 days of treatment and follow-up evaluations extending to 6 weeks.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Percent predicted FEV1 ≥ 40% by spirometry during screening
Ability to demonstrate correct use of the smart dry powder inhaler at screening
Stable treatment regimen for muco-obstructive diseases for at least 28 days before study and willingness to remain on it during the study
Stable disease for at least 28 days before screening and through to treatment start
Chronic sputum production of at least 1 teaspoon per day (Part B participants)
Ability to produce sputum samples suitable for biomarker research (Part B participants)
Availability of a blood sample for biomarker research (Part B participants)
Diagnosis of bronchiectasis involving at least 2 lung lobes, including one in the right lung (Non-cystic Fibrosis Bronchiectasis participants in Cohorts 1, 2, and 3)
COPD defined as post-bronchodilator FEV1/FVC ratio less than 0.7 with chronic bronchitis and smoking history or risk factors (COPD participants in Cohorts 1, 2, and 4)

You will not qualify if you...

Pregnant or breastfeeding or planning pregnancy during the study or required contraception period
Significant bronchodilator response greater than 10% predicted change in FEV1 or FVC
Use of prohibited medications
Acute respiratory infection within 28 days before screening
Significant hemoptysis greater than 60 mL within 3 months before screening
Known clinically significant immunodeficiency
Substance abuse within 12 months before screening
Poor peripheral venous access
Receipt of blood products within 120 days before screening
Any medical condition or lab abnormality that poses safety risks or affects study results
History of thoracic or metastatic cancer within 5 years before screening
Clinically significant abnormal electrocardiogram or prolonged QT interval
More than 2 chest CTs or high lung radiation exposure within 12 months (Part B participants)
Bronchiectasis due to cystic fibrosis, primary ciliary dyskinesia, non-tuberculous mycobacterial infection, chronic aspiration, or interstitial lung disease (Non-cystic Fibrosis Bronchiectasis participants)
Diagnosis of asthma as primary respiratory disease
Bronchiectasis exacerbation within 28 days before screening or not returned to baseline
Current smoking within 3 months before screening
COPD as primary driver of respiratory disease (Non-cystic Fibrosis Bronchiectasis Cohort 3)
COPD exacerbation within 28 days before screening or not returned to baseline
Asthma/COPD overlap syndrome (COPD participants)

Research Team

Reference Study ID Number: GB45429 https://forpatients.roche.com/

Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Phase 1 Study to Assess Safety and Effects of Inhaled GDC-6988 in Adults With Muco-obstructive Lung Diseases

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria