Clinical Study of Inhaled GB002 for Treatment of WHO Group I Pulmonary Arterial Hypertension

Completed · Phase 1 · Has a placebo group

Conditions studied: Pulmonary Arterial Hypertension

In brief

This is a Phase 1B, randomized, participant- and investigator-blinded, placebo-controlled, multi-center clinical trial to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and biomarkers of inhaled GB002 in adults with World Health Organization (WHO) Group 1 Pulmonary Arterial Hypertension (PAH).

Key facts

Study ID

NCT03926793

Run by

GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.

People needed

8

Starts

2020-02-04

Expected to finish

2021-05-05

Last updated by the study team

2021-09-01

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult (males and females) aged 18 to 75 years (inclusive) with pulmonary arterial hypertension (PAH) (Main study)
• A current diagnosis of symptomatic PAH classified by one of the following (Main and OLE study):
• Idiopathic (IPAH) or heritable pulmonary arterial hypertension (HPAH)
• PAH associated with one of the following connective tissue diseases (CTDs):
• systemic sclerosis, rheumatoid arthritis, mixed CTD or overlap syndrome, or systemic lupus erythematosus
• PAH associated with anorexigen or methamphetamine use
• World Health Organization (WHO)/New York Heart Association (NYHA) functional class II-IV symptomatology (Main study)

You may not qualify if…

• Clinically significant systemic hypertension or hypotension (Main and OLE study)
• History of left-sided heart disease and/or clinically significant cardiac disease (Main and OLE study)
• 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)
• NOTE: Additional inclusion/exclusion criteria may apply, per protocol.

Where it is running

• 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

Full record on ClinicalTrials.gov

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