An Open-Label, Dose Titration Study to Assess the Safety, Tolerability, and Hemodynamic Response of PB1046, A Sustained-Release Analogue of Vasoactive Intestinal Peptide, In Adult Subjects With Pulmonary Arterial Hypertension
PB1046-PT-CL-0005 is an open-label, dose-titration study to assess the safety, tolerability, and hemodynamic effects of individually dose-titrated PB1046 administered by weekly subcutaneous injection for 8 weeks in adult subjects with PAH who have a permanently implanted hemodynamic monitor in the distal pulmonary artery. The primary objectives of the study are to assess the overall safety, tolerability, and hemodynamic profile of a PB1046 across an individually titrated dose range.
• Willing and able to provide written informed consent and follow all study-related procedures;
• Confirmed diagnosis of Pulmonary Arterial Hypertension (WHO Group 1) and WHO Functional Class II or III by clinical diagnostic criteria assessed by the Investigator and have a permanently implanted pulmonary artery hemodynamic monitor (IHM);
• Adult subjects ≥18 years of age willing and able to utilize contraception as needed for 30 days after their last dose of study drug;
• Body mass index ≥ 18 kg/m2 and ≤ 47 kg/m2;
• Receipt of Investigator-directed stable (no change in dose or addition or removal of a therapy) medical-therapy in accordance with local standard of care for the management of PAH for 30 days prior to screening and between screening and first dose and are in stable clinical condition;
• Screening hemoglobin ≥ 9.0 g/dL secondary to the volume of blood to be collected during the study period;
• Willing and able to return to the study unit for specified study visits, or accommodate home visits;
• Willing and able to transmit hemodynamics via IHM and monitor systemic blood pressure while at home and record results.