This is a Phase Ib/IIa clinical study of IMC-003 treatment in pulmonary arterial hypertension (PAH) patients receiving background therapy
Age screening between 18 and 75 years (inclusive), regardless of gender.
Patients diagnosed with WHO Group 1 pulmonary arterial hypertension (PAH) confirmed by right heart catheterization (RHC) before initial dosing (see Appendix 1), including the following subtypes: idiopathic PAH; heritable PAH; drug- or toxin-induced PAH; PAH associated with connective tissue diseases that is inactive; PAH associated with simple congenital heart defects with systemic-to-pulmonary shunts, at least one year post-correction surgery.
Symptomatic pulmonary arterial hypertension, WHO functional class II or III.
Must also meet the following hemodynamic criteria: mean pulmonary arterial pressure (mPAP) ≥25 mmHg at rest; pulmonary artery wedge pressure (PAWP) ≤15 mmHg.
Diagnosed with pulmonary hypertension of WHO Group 2, 3, 4, or 5.
Diagnosed with the following PAH subtypes of WHO Group 1: HIV-associated PAH, portal hypertension-associated PAH, schistosomiasis-associated PAH, PAH related to pulmonary veno-occlusive disease or pulmonary capillary hemangiomatosis, patients with PAH known to have a positive acute pulmonary vasoreactivity test.
Poorly controlled hypertension after screening: seated systolic BP >160 mmHg or seated diastolic BP >100 mmHg, or pre-dose systolic BP <90 mmHg on C1D1.
Pre-dose electrocardiogram (ECG) Fridericia-corrected QT interval (QTcF) ≥470 ms for men, ≥480 ms for women; or personal or family history of long QT syndrome (LQTS) or sudden cardiac death.
Parallel
IMC-003 and PAH background therapy
DrugSubjects will receive 8 injections of IMC-003 and will also need to have stable background treatment for pulmonary arterial hypertension.
IMC-003 placebo and PAH background therapy
DrugSubjects will receive 8 injections placebo of IMC-003 and will also need to have stable background treatment for pulmonary arterial hypertension.
Evaluate the safety and tolerability of multiple subcutaneous injections of IMC-003 in patients with pulmonary arterial hypertension, providing a basis for selecting the Recommended Phase 2 Dose (RP2D) of this product.
At 24 weeks of treatment, the change in hemodynamic indicator pulmonary vascular resistance (PVR) from baseline.
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