GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)

Inclusion Criteria

• A current diagnosis of symptomatic PAH classified by one of the following:
• Idiopathic PAH (IPAH) or heritable pulmonary arterial hypertension (HPAH).
• PAH associated with connective tissue disease (CTD-APAH).
• PAH associated with anorexigen or methamphetamine use.
• Congenital heart disease with simple systemic to pulmonary shunt at least 1 year after surgical repair.
• 6MWD ≥ 150 meters and ≤ 550 meters at screening.
• WHO FC II or III symptomatology.
• Treatment with standard of care PAH background therapies.
• Documentation of cardiac catheterization within the screening period that is consistent with the diagnosis of PAH and meeting all the following criteria, to be confirmed by a central hemodynamic core laboratory:
• Mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg (at rest), AND
• PVR ≥ 400 dyne•sec/cm5, AND
• Pulmonary capillary wedge pressure (PCWP) or left ventricular-end diastolic pressure (LVEDP) ≤12 mm Hg if PVR ≥400 to 160 mm Hg or sitting diastolic blood pressure > 100 mm Hg during screening visit after a period of rest.
• Systolic blood pressure 2 x ULN or Total Bilirubin ≥ 2 x ULN.
• History of malignancy within 5 years prior to screening.
• History of a potentially life-threatening cardiac arrhythmia with an ongoing risk.
• Severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or IP administration (eg; history intracranial hemorrhage).
• Chronic renal insufficiency as defined by an estimated glomerular filtration rate (eGFR) 480 msec recorded on a screening or baseline ECG or receiving concurrent treatment with medications that prolong QT interval.
• Have any other condition or reason that, in the opinion of the Investigator or Medical Monitor, would prohibit the subject from participating in the study.

NOTE: Additional inclusion/exclusion criteria may apply, per protocol.