RecruitingPhase 1

A Study to Test the Safety and Effects of Inhaled GDC-6988 in Participants 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests an inhaled drug called GDC-6988 for people with lung diseases that cause mucus buildup. It looks at the drug’s safety, how well people tolerate it, and its effects.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • A breathing test must show FEV1 of at least 40% of the expected value. FEV1 measures how much air you can blow out in one second.
  • You must be able to use the study’s smart dry powder inhaler correctly.
  • Your lung treatment must stay the same for at least 28 days before study treatment and throughout the study.
  • Your lung disease must be stable for at least 28 days before screening and until study treatment starts.
  • For Part B: You must cough up at least 1 teaspoon of mucus daily and provide suitable mucus and blood samples for research.
  • For the bronchiectasis groups: A past chest CT scan must show widened, damaged airways in at least two lung sections, including one in the right lung.
  • For the COPD groups: After medicine that opens the airways, a breathing test must show an FEV1/FVC ratio below 0.7. This compares air blown out in one second with the total air blown out.
  • For the COPD groups: You must have cough and excess mucus for over 3 months a year for at least 2 years. You must also be a former smoker with at least 10 pack-years of smoking, such as one pack daily for 10 years, or a nonsmoker with a documented COPD risk factor.

Who can't join

  • You are pregnant, breastfeeding, or planning pregnancy during the study or while birth control is required.
  • You use medicines not allowed in the study, or airway-opening medicine causes a large change in your breathing test results.
  • You had a lung infection within 28 days before screening, or coughed up more than 60 mL of blood within 3 months.
  • You have a serious immune system problem, recent substance abuse, veins that are hard to draw blood from, or received blood products within 120 days before screening.
  • You have certain abnormal heart tests, had cancer in the chest or cancer that spread within 5 years, or have another health problem that could make the study unsafe or affect its results.
  • For Part B: You had more than two chest CT scans, or other tests exposing the lungs to more than 100 mSv of radiation, within 12 months before screening.
  • For the bronchiectasis groups: Certain causes of airway damage, asthma as the main lung disease, a recent or ongoing flare-up, or smoking or vaping tobacco or marijuana within 3 months can exclude you. In Cohort 3, COPD as the main lung disease also excludes you.
  • For the COPD groups: You had a flare-up within 28 days before screening, have not returned to your usual health after a flare-up, or have both asthma and COPD.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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 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, 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 milliliter (mL) within 3 months prior to screening * Known immunodeficiency that, in the investigator's judgment, is clinically significant and places the individual at a substantially elevated risk for opportunistic infections. * 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 in Part B -More than 2 chest CTs or other procedures known to expose the lungs to greater than 100 millisievert (mSv) within 12 months prior to screening 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 * Diagnosis of asthma, that in the investigator's judgment, is the primary driver of the individual's respiratory disease (e.g., primary asthma with incidental bronchiectasis findings) * 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 NCFB in Cohort 3 \- Diagnosis of COPD that, in the investigator's judgment, is the primary driver of the individual's respiratory disease (e.g., primary COPD with incidental bronchiectasis findings) Additional Exclusion Criteria for Participants With COPD (Cohort 1, Cohort 2, and Cohort 4): * COPD exacerbation within 28 days prior to screening or that has not returned to baseline * Asthma/COPD overlap syndrome

Study sites (7)

AL

CA

KS

NC

PA

TX