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

Condition(s) studied

Investigational drug(s) / intervention(s)

RABI-767: 125 mg single-dose given by endoscopic-ultrasound (EUS) guided peripancreatic injection.

Study summary

The goal of this clinical trial is to test the safety and effectiveness of a single dose of RABI-767 given by endoscopic ultrasound (EUS) guided peripancreatic injection in participants with predicted severe acute pancreatitis.

The main question the study aims to answer is:

• Is a single-dose of RABI-767 given by EUS-guided peripancreatic injection safe in patients with predicted severe acute pancreatitis.

The study also aims to answer:

• Is a single-dose of RABI-767 given by EUS-guided peripancreatic injection effective in treating patients with predicted severe acute pancreatitis.

Study participants will be randomly assigned (like the flip of a coin) to receive a single dose of RABI-767 plus supportive care or supportive care only.

The study sponsor will compare safety and efficacy data collected from participants who receive RABI-767 to participants who receive supportive care only to test if RABI-767 is safe and effective.

Eligibility

Primary outcome measure(s)

• Number of Participants with Adverse Events — Enrollment/Randomization to Day 28 (or hospital discharge, if earlier)
  An adverse event (AE) is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the study intervention, regardless of its causal relationship to the study intervention. For the purposes of this study, any AE occurring in any study participant (regardless of treatment group assignment) at any time after enrollment/randomization, even if no study intervention has been administered, will be recorded.
• Number of Participants with Serious Adverse Events — Enrollment/Randomization to Day 35 Follow-up
  A serious adverse event (SAE) is an AE, regardless of causality, that fulfills one or more protocol defined criteria for being serious.
• Change from Baseline in Clinical Chemistry Parameters — Baseline to Day 7
• Change from Baseline in Hematology Parameters — Baseline to Day 7
• Change from Baseline in Vital Signs — Baseline to Day 7
• Change from Baseline in Pulse Oximetry and Oxygen Delivery Measurements — Baseline to Day 7

Trial sites (16)