Actively Recruiting
A Phase Ic, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, and Activity of Inhaled GDC-6988 in Patients With Muco-obstructive Disease
Led by Genentech, Inc. · Updated on 2026-06-04
128
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating inhaled GDC-6988 for its safety, tolerability, and activity in people with muco-obstructive diseases, including non-cystic fibrosis bronchiectasis and chronic obstructive pulmonary disease (COPD). This phase 1 open-label study aims to understand how the drug affects lung function and mucus properties, with careful monitoring of any side effects. Participants are divided into four groups receiving different dosing schedules of GDC-6988 using a dry powder inhaler. One group receives low-dose followed by high-dose for two days, another receives low-dose followed by high-dose twice daily for 14 days, and two groups receive low-dose twice daily for 14 days. The study evaluates drug effects over these dosing periods. During the study, participants will undergo lung function tests, including spirometry, and provide sputum and blood samples for biomarker analysis. Safety is monitored through adverse event tracking and lung function assessments up to six weeks. Researchers will measure changes in mucus properties and lung clearance using imaging and laboratory tests. Participants remain on stable treatment regimens throughout the study, which includes careful evaluation of lung function and safety over time.
CONDITIONS
Brief Title
A Study to Test the Safety and Effects of Inhaled GDC-6988 in Participants With Muco-obstructive Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Percent predicted FEV1 of 40% or higher by spirometry during screening
- Ability to correctly use the smart dry powder inhaler device
- Stable treatment regimen for muco-obstructive diseases for at least 28 days before study and willingness to remain on it
- Stable disease for at least 28 days before screening and until study treatment begins
- For Part B: Chronic sputum production of at least 1 teaspoon per day
- For Part B: Ability to provide sputum samples suitable for lab testing
- For Part B: Availability of blood samples for biomarker research
- For Non-cystic Fibrosis Bronchiectasis participants (Cohorts 1, 2, 3): Diagnosis confirmed by chest CT involving at least 2 lobes including right lung
- For COPD participants (Cohorts 1, 2, 4): COPD defined by post-bronchodilator FEV1/FVC ratio below 0.7
- For COPD participants: Chronic bronchitis with cough and sputum for more than 3 months per year for at least 2 years
- Former smoker with at least 10 pack-year history or non-smoker with documented COPD risk factor
You will not qualify if you...
- Pregnant or breastfeeding, or planning pregnancy during the study or contraception period
- Significant bronchodilator response greater than 10% change in FEV1 or FVC
- Use of prohibited medications
- Acute respiratory infection within 28 days before screening
- Significant hemoptysis over 60 mL in last 3 months
- Clinically significant immunodeficiency
- Known substance abuse within past 12 months
- Poor vein access
- Blood product receipt within 120 days before screening
- Any medical condition or lab finding that might risk safety or affect results
- History of thoracic or metastatic cancer within 5 years
- Clinically significant abnormal ECG or QTcF interval over 450 ms (males) or 470 ms (females)
- For Part B: More than 2 chest CTs or procedures exposing lungs to over 100 mSv in past 12 months
- For Non-cystic Fibrosis Bronchiectasis participants: Bronchiectasis due to cystic fibrosis, primary ciliary dyskinesia, non-tuberculous mycobacterial infection, chronic aspiration, or traction bronchiectasis from interstitial lung disease
- Diagnosis of asthma as primary respiratory disease
- Bronchiectasis exacerbation within 28 days prior to screening or not returned to baseline
- Current smoker or use of inhaled tobacco or marijuana products within 3 months
- For NCFB Cohort 3: COPD as primary respiratory disease
- For COPD participants: COPD exacerbation within 28 days prior to screening or not returned to baseline
- Asthma/COPD overlap syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 14 days
Participants receive inhaled GDC-6988 using a dry powder inhalation device in varying doses and schedules depending on their cohort assignment.
Daily visits or assessments during dosing period
Duration - Up to 6 weeks
Participants are monitored for safety, tolerability, and activity of GDC-6988 after treatment ends.
Periodic visits for safety and spirometry assessments
Trial Site Locations
Total: 7 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Accel Research Site - Achieve - Birmingham - ERN - PPDS
Vestavia Hills, Alabama, United States, 35216-1927
Withdrawn
3
Stanford Center for Excellence in Pulmonary Biology
Palo Alto, California, United States, 94304
Actively Recruiting
4
University of Kansas Medical Center-Kansas City-3901 Rainbow Blvd
Kansas City, Kansas, United States, 66160 8500
Actively Recruiting
5
University of North Carolina Clinical Research Center
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
6
UPMC Montefiore Hospital
Pittsburgh, Pennsylvania, United States, 15213 3236
Actively Recruiting
7
TTS Research
Boerne, Texas, United States, 78006
Completed
Research Team
R
Reference Study ID Number: GB45429 https://forpatients.roche.com/
F
Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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