Clinical Study of Inhaled GB002 for Treatment of WHO Group I Pulmonary Arterial Hypertension
NCT ID: NCT03926793
Last Updated: 2021-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
8 participants
INTERVENTIONAL
2020-02-04
2021-05-05
Brief Summary
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Detailed Description
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In this Phase 1B study, two dose levels of GB002 will be tested in adult participants with PAH. Four participants in cohort 1 will be randomized to receive up to two daily doses of either active drug or placebo, with 3 subjects receiving GB002 and 1 subject receiving placebo. An additional 4 participants (3 active and 1 placebo) may be added to cohort 1 at the discretion of the Data Review Committee (DRC). The dose and dosing interval (i.e., once daily or twice daily) for the second cohort will be determined by review of the safety, tolerability, and drug levels in the blood from cohort 1. Cohort 2 participants will also be randomized such that 6 subjects receive GB002 and 2 subjects receive placebo.
Eligible subjects who have completed the 2 week treatment period have the option to participate in a 24 week open label extension.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Cohort 1
Patients will be randomized to receive inhaled GB002 or Placebo daily for 14 days
GB002
GB002 low dose or high dose for inhalation
Placebo
Placebo for inhalation
Generic Dry Powder Inhaler
Generic dry powder inhaler for GB002 or Placebo delivery
Cohort 2
Patients will be randomized to receive inhaled GB002 or Placebo daily for 14 days
GB002
GB002 low dose or high dose for inhalation
Placebo
Placebo for inhalation
Generic Dry Powder Inhaler
Generic dry powder inhaler for GB002 or Placebo delivery
Open Label Extension
Eligible subjects may participate in the Open Label Extension (OLE) study for a period of 24 weeks.
GB002
GB002 low dose or high dose for inhalation
Generic Dry Powder Inhaler
Generic dry powder inhaler for GB002 or Placebo delivery
Interventions
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GB002
GB002 low dose or high dose for inhalation
Placebo
Placebo for inhalation
Generic Dry Powder Inhaler
Generic dry powder inhaler for GB002 or Placebo delivery
Eligibility Criteria
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Inclusion Criteria
2. A current diagnosis of symptomatic PAH classified by one of the following (Main and OLE study):
1. Idiopathic (IPAH) or heritable pulmonary arterial hypertension (HPAH)
2. PAH associated with one of the following connective tissue diseases (CTDs):
systemic sclerosis, rheumatoid arthritis, mixed CTD or overlap syndrome, or systemic lupus erythematosus
3. PAH associated with anorexigen or methamphetamine use
3. World Health Organization (WHO)/New York Heart Association (NYHA) functional class II-IV symptomatology (Main study)
Exclusion Criteria
2. History of left-sided heart disease and/or clinically significant cardiac disease (Main and OLE study)
3. History of decompensated right heart failure within 30 days of screening (e.g., hospitalization for PAH or the need to add an additional PAH medication) (Main study)
18 Years
75 Years
ALL
No
Sponsors
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GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
INDUSTRY
Responsible Party
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Locations
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UCSD Medical Center
La Jolla, California, United States
University of California Davis Medical Center
Sacramento, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Norton Pulmonary Specialists
Louisville, Kentucky, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Duke Early Phase Research
Durham, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
University of Pittsburgh Medical Center Montefiore University Hospital
Pittsburgh, Pennsylvania, United States
VitaLink Research - Anderson
Anderson, South Carolina, United States
Golden Jubilee National Hospital
Glasgow, , United Kingdom
Hammersmith Hospital, Imperial Healthcare NHS Trust
London, , United Kingdom
Countries
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Other Identifiers
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GB002-1101
Identifier Type: -
Identifier Source: org_study_id
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