A Phase Ic, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, and Activity of Inhaled GDC-6988 in Patients With Muco-obstructive Disease
Genentech, Inc.
Summary
This study evaluates the safety, tolerability, and activity of inhaled GDC-6988 in participants with muco-obstructive disease.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Percent predicted FEV1 ≥ 40% by spirometry during screening * Ability to demonstrate correct use of the smart DPI at screening, in the investigator's judgment * On a stable treatment regimen for muco-obstructive diseases for ≥ 28 days prior to initiation of study treatment and willingness to remain on the stable treatment regimen through completion of study * Stable disease for ≥ 28 days prior to screening and through to initiation of study treatment Additional Inclusion Criteria for Participants in Part B * Chronic sputum production of ≥1 teaspoon per day as reported…
Interventions
- DrugGDC-6988
GDC-6988 will be administered using a dry powder inhalation (DPI) device.
Locations (7)
- University of Alabama at BirminghamBirmingham, Alabama
- Accel Research Site - Achieve - Birmingham - ERN - PPDSVestavia Hills, Alabama
- Stanford Center for Excellence in Pulmonary BiologyPalo Alto, California
- University of Kansas Medical Center-Kansas City-3901 Rainbow BlvdKansas City, Kansas
- University of North Carolina Clinical Research CenterChapel Hill, North Carolina
- UNC Investigational Drug ServicesMorrisville, North Carolina