A Study to Test the Safety and Effects of Inhaled GDC-6988 in Participants With Muco-obstructive … (NCT06603246) | Clinical Trial Compass
RecruitingPhase 1/2
A Study to Test the Safety and Effects of Inhaled GDC-6988 in Participants With Muco-obstructive Disease
United States128 participantsStarted 2024-11-18
Plain-language summary
This study evaluates the safety, tolerability, and activity of inhaled GDC-6988 in participants with muco-obstructive disease.
Who can participate
Age range18 Years
SexALL
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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 in the sputum volume item
* Ability to produce a sputum sample that is suitable for central laboratory determination of mucus percent solids and sialic acid concentration exploratory biomarker research, and biomarker assay development
* Availability of a representative blood sample for exploratory biomarker research and biomarker assay development
Additional Inclusion Criteria for Participants With Non-cystic Fibrosis Bronchiectasis (NCFB) (Cohort 1, Cohort 2, and Cohort 3):
\- Diagnosis of bronchiectasis on the basis of prior chest computed tomography (CT), involving at least 2 lobes, with at least one lobe of involvement in the right lung as assessed by the investigator
Additional Inclusion Criteria for Participants With Chronic Obstructive Pulmonary Disease (COPD) (Cohort 1, Cohort 2, and Cohort 4):
* COPD defined as post-bronchodilator FEV1/FVC ratio of \<0.7
* Chronic bronchitis…
What they're measuring
1
Percentage of Participants With Adverse Events (AEs), with Severity Assessed by Division of Acquired Immunodeficiency Syndrome (DAIDS) Toxicity Grading Scale
Timeframe: From baseline up to 6 weeks
2
Percentage of Participants With Spirometry Abnormalities
Timeframe: From baseline up to 6 weeks
Trial details
NCT IDNCT06603246
SponsorGenentech, Inc.
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2027-11-15
Contact for this trial
Reference Study ID Number: GB45429 https://forpatients.roche.com/