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

Description

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

Conditions

Non Cystic Fibrosis Bronchiectasis, Chronic Obstructive Pulmonary Disease

Study Overview

Study Details

Study overview

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

A Phase Ic, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, and Activity of Inhaled GDC-6988 in Patients With Muco-Obstructive Disease

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

Condition
Non Cystic Fibrosis Bronchiectasis
Intervention / Treatment

-

Contacts and Locations

Boerne

Texas Research Institute/TTS, Boerne, Texas, United States, 78006

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)
  • * 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
  • * 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
  • * COPD exacerbation within 28 days prior to screening or that has not returned to baseline
  • * Asthma/COPD overlap syndrome

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Genentech, Inc.,

Clinical Trials, STUDY_DIRECTOR, Genentech, Inc.

Study Record Dates

2026-03-15