Evaluating a Single Dose of RABI-767 by Endoscopic Ultrasound Injection Compared to Standard Care in Adults with Predicted Severe Acute Pancreatitis

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a single dose of RABI-767 administered by endoscopic ultrasound EUS guided peripancreatic injection in adults with predicted severe acute pancreatitis. This phase 2a clinical trial compares RABI-767 plus supportive care to supportive care alone to better understand if this treatment is safe and beneficial. The study is sponsored by Panafina, Inc. and focuses on adults aged 18 to 85 years with specific imaging and clinical criteria. Participants are randomly assigned to receive either a single 125 mg dose of RABI-767 by EUS-guided injection alongside standard care or standard care alone without the investigational drug. The trial uses a parallel design to compare these two groups. The single-dose RABI-767 administration occurs early in the treatment phase, with follow-up assessments extending up to 60 days after dosing. Throughout the study, participants will be monitored closely for adverse events and changes in clinical chemistry, hematology, vital signs, oxygen measurements, and pancreatitis severity scores. Imaging studies such as contrast-enhanced CT or MRI will assess pancreatic changes. Researchers will track hospital stay duration, intensive care use, and rehospitalizations. Safety and efficacy outcomes are collected up to 60 days following treatment, with the overall participation lasting several weeks to months depending on individual recovery and follow-up timing.

A Study to Evaluate the Safety and Efficacy of a Single Dose of RABI-767 in Participants With Acute Pancreatitis