The primary objective for this trial is to determine the effect of GB002 (seralutinib) on improving pulmonary hemodynamics in subjects with World Health Organization (WHO) Group 1 PAH who are Functional Class (FC) II and III. The secondary objective for this trial is to determine the effect of GB002 (seralutinib) on improving exercise capacity in this population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
86
Capsule containing GB002 (seralutinib)
Matching capsule containing placebo
Generic dry powder inhaler for GB002 (seralutinib) or placebo delivery
Change From Baseline to Week 24 in Pulmonary Vascular Resistance (PVR)
PVR was evaluated using right heart catheterization (RHC).
Time frame: Baseline, Week 24
Change From Baseline to Week 24 in Distance Achieved on the Six-Minute Walk Test (6MWT)
The 6MWT measures the distance a participant is able to walk quickly on a flat, hard surface in a period of 6 minutes.
Time frame: Baseline, Week 24
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