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NCT06603246 | RECRUITING | Non Cystic Fibrosis Bronchiectasis

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

Genentech, Inc.

Brief Summary:

This study evaluates the safety, tolerability, and activity of inhaled GDC-6988 in participants with muco-obstructive disease.

Condition or disease

Non Cystic Fibrosis Bronchiectasis

Chronic Obstructive Pulmonary Disease

Intervention/treatment

GDC-6988

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 128 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase Ic, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, and Activity of Inhaled GDC-6988 in Patients With Muco-Obstructive Disease
Actual Study Start Date : 2024-11-18
Estimated Primary Completion Date : 2027-07-15
Estimated Study Completion Date : 2027-07-15

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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 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 and Cohort 4)
      • * COPD defined as post-bronchodilator FEV1/FVC ratio of \<0.7
      • * Chronic bronchitis, with a definition including chronic cough and excessive sputum production for more than 3 months per year for at least 2 years prior to screening
      • * Former smoker with a minimum of 10 pack-year history (e.g., 20 cigarettes/day for 10 years) or non-smoker with at least one documented COPD risk factor
      Exclusion Criteria
      • * 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
      • * Significant hemoptysis greater than 60 mL within 3 months prior to screening
      • * Known immunodeficiency including, but not limited to, human immunodeficiency virus (HIV) infection with CD4+ T cell count \<200 cells/mm\^3 or an acquired immunodeficiency syndrome (AIDS)-defining condition 6 months prior to screening
      • * Known substance abuse, in the investigator's judgment, within 12 months prior to screening
      • * Poor peripheral venous access
      • * Receipt of blood products within 120 days prior to screening
      • * Any medical condition or abnormal clinical laboratory finding that, in the investigator's judgment, would preclude the individual's safe participation in and completion of the study or could affect the interpretation of the results
      • * History of thoracic or metastatic malignancy within 5 years prior to screening
      • * Known history of a clinically significant abnormal electrocardiogram (ECG), or presence of an abnormal ECG that is deemed clinically significant by the investigator
      • * QT interval corrected through use of Fridericia's formula (QTcF) \>450 milliseconds (ms) for males or \>470 ms for females
      • Additional Exclusion Criteria for Participants with NCFB (Cohort 1, Cohort 2, and Cohort 3)
      • * Bronchiectasis primarily due to cystic fibrosis, primary ciliary dyskinesia, non-tuberculous mycobacterial infection, chronic aspiration, or predominantly traction bronchiectasis due to interstitial lung disease (ILD), in the investigator's judgment
      • * Primary diagnosis of COPD or asthma, in the investigator's judgment
      • * NCFB exacerbation within 28 days prior to screening or that has not returned to baseline
      • * Current smoker: Current smoking is defined as any use of inhaled tobacco products or inhaled marijuana within 3 months prior to screening, through use of cigarettes, cigars, electronic cigarettes, vaporizing devices, or pipes.
      • Additional Exclusion Criteria for Participants with COPD (Cohort 1 and Cohort 4)
        • * COPD exacerbation within 28 days prior to screening or that has not returned to baseline
        • * Asthma/COPD overlap syndrome
A Study to Test the Safety and Effects of Inhaled GDC-6988 in Participants With Muco-Obstructive Disease

Location Details

NCT06603246

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, alabama

University of Alabama at Birmingham

Birmingham, alabama, United States, 35233

WITHDRAWN

United States, alabama

Accel Research Site - Achieve - Birmingham - ERN - PPDS

Vestavia Hills, alabama, United States, 35216-1927

RECRUITING

United States, California

Stanford Center for Excellence in Pulmonary Biology

Palo Alto, California, United States, 94304

RECRUITING

United States, Kansas

University of Kansas Medical Center-Kansas City-3901 Rainbow Blvd

Kansas City, Kansas, United States, 66160 8500

RECRUITING

United States, North Carolina

University of North Carolina Clinical Research Center

Chapel Hill, North Carolina, United States, 27514

RECRUITING

United States, Pennsylvania

UPMC Montefiore Hospital

Pittsburgh, Pennsylvania, United States, 15213 3236

COMPLETED

United States, Texas

TTS Research

Boerne, Texas, United States, 78006