A Study to Test the Safety and Effects of Inhaled GDC-6988 in Participants With Muco-obstructive Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGenentech, Inc.
About this trial
This study evaluates the safety, tolerability, and activity of inhaled GDC-6988 in participants with muco-obstructive disease.
Eligibility criteria
Qualifiers
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
Disqualifiers
Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the timeframe in which contraception is required
Known significant bronchodilator response of >10% predicted change in FEV1 or FVC, in the investigator's judgment
Use of any prohibited medications
Acute respiratory infection within 28 days of screening
Trial design
Treatments tested in this trial
- GDC-6988
Treatment groups
128 Participants
are divided into 1 treatment groupLocations
7Alabama
University of Alabama at Birmingham35233, Birmingham United States
Accel Research Site - Achieve - Birmingham - ERN - PPDS35216-1927, Vestavia Hills United States
California
Stanford Center for Excellence in Pulmonary Biology94304, Palo Alto United States
Kansas
University of Kansas Medical Center-Kansas City-3901 Rainbow Blvd66160 8500, Kansas City United States
Sponsors and collaborators
Genentech, Inc.
Lead sponsor
Source ClinicalTrials.gov