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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Genentech, Inc.
Study ID
NCT06603246
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GDC-6988 — DRUG
    GDC-6988 will be administered using a dry powder inhalation (DPI) device.

Study Details

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

Key Dates

Start date
Nov 18, 2024
Status verified
Jun 2026
Primary completion
Nov 15, 2027
Completion
Nov 15, 2027

Study Design

Enrollment
128 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: GDC-6988
    Participants in Cohort 1 will receive low-dose GDC-6988, twice a day (BID) on Day 1, followed by high-dose, BID on Day 2. Participants in Cohort 2 will receive low-dose, followed by high-dose GDC-6988, BID for 14 days. Participants in Cohorts 3 and 4 will receive low-dose GDC-6988, BID for 14 days.

Primary Outcome Measure

Percentage of Participants With Adverse Events (AEs), with Severity Assessed by Division of Acquired Immunodeficiency Syndrome (DAIDS) Toxicity Grading Scale [ Time Frame: From baseline up to 6 weeks ]

Central Contacts

  • Reference Study ID Number: GB45429 https://forpatients.roche.com/
    888-662-6728 (U.S. Only)
    [email protected]
  • Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Locations (7)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233-
Accel Research Site - Achieve - Birmingham - ERN - PPDSVestavia HillsAlabama35216-1927-
Stanford Center for Excellence in Pulmonary BiologyPalo AltoCalifornia94304-
University of Kansas Medical Center-Kansas City-3901 Rainbow BlvdKansas CityKansas66160 8500-
University of North Carolina Clinical Research CenterChapel HillNorth Carolina27514-
UPMC Montefiore HospitalPittsburghPennsylvania15213 3236-
TTS ResearchBoerneTexas78006-

Find similar trials in Birmingham, AL

By condition
COPD
By specialty
PulmonologyLung disease
By research site
University of Alabama at Birmingham· Birmingham, ALAccel Research Site - Achieve - Birmingham - ERN - PPDS· Vestavia Hills, ALStanford Center for Excellence in Pulmonary Biology· Palo Alto, CAUniversity of Kansas Medical Center-Kansas City-3901 Rainbow Blvd· Kansas City, KSUniversity of North Carolina Clinical Research Center· Chapel Hill, NCUPMC Montefiore Hospital· Pittsburgh, PA

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