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INVESTIGATOR’S AGREEMENTInvestigator’s Agreement • December 17th, 2021
Name of Sponsor/Company:La Jolla Pharmaceutical Company (La Jolla) Name of Investigational Product:LJPC-501 (angiotensin II) Name of Active Ingredient:angiotensin II Title of study:An Open-label, Multi-Center Study of LJPC-501 in Pediatric Patients Who Remain Hypotensive Despite Receiving Fluid Therapy and Vasopressor Therapy Number of study center(s): Approximately 10 Objectives:Primary:• To evaluate the effect of LJPC-501 infusion on mean arterial pressure (MAP) or reduction in sum norepinephrine-equivalent dose (NED), at Hour 2 after the start of LJPC-501, in pediatric patients who remain hypotensive despite receiving fluid therapy and vasopressor therapy.Secondary:• To establish the safety and tolerability of LJPC-501 in pediatric patients• To evaluate the change in MAP over 24 hours after the start of LJPC-501• To evaluate the change in serum lactate concentrations• To evaluate change in Pediatric Logistic Organ Dysfunction (PELOD) scores Methodology:ScreeningDuring Screening, the
