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

  • Respiratory Disorder
  • Chronic Obstructive Pulmonary Disease (COPD)
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Not yet recruiting

This trial runs in
N/A
Trial Identifier:

NCT06603246 GB45429

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

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      Trial Summary

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

      Genentech, Inc. Sponsor
      Phase 1 Phase
      NCT06603246, GB45429 Trial Identifier
      GDC-6988 Treatments
      Non Cystic Fibrosis Bronchiectasis, Chronic Obstructive Pulmonary Disease Condition
      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

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      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 NCFB (Cohort 1, Cohort 2, and Cohort 3):

      • Diagnosis of bronchiectasis on the basis of prior chest 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 COPD (Cohort 1 and Cohort 4):

      • COPD defined as post-bronchodilator FEV1/forced vital capacity (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)
      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, HIV infection with CD4+ T cell count <200 cells/mm3 or an 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 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 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

      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

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