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

Overview

About this study

The purpose of this study is 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).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.

Inclusion Criteria: 

  • Adults (male and female) aged 18 to 75 years old (inclusive)
  • Adults with pulmonary arterial hypertension (PAH).
  • A current diagnosis of symptomatic PAH classified by one of the following:
    • Idiopathic (IPAH) or heritable pulmonary arterial hypertension (HPAH);
    • PAH associated with one of the following connective tissue diseases (CTDs): limited scleroderma, mixed connective tissue disease 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.

Exclusion Criteria:

  • Clinically significant systemic hypertension or hypotension.
  • History of left-sided heart disease and/or clinically significant cardiac disease.
  • 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).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Charles Burger, M.D.

Open for enrollment

Contact information:

Pulmonary Hypertension Research Team

(507)538-7297

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20482112

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