NCT06080789 · Panafina, Inc.
A Study to Evaluate the Safety and Efficacy of a Single Dose of RABI-767 in Participants With Acute Pancreatitis
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
RABI-767
125 mg single-dose given by endoscopic-ultrasound (EUS) guided peripancreatic injection.
Primary outcome measures
Number of Participants with Adverse Events
Time frame: 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
Time frame: 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
Time frame: Baseline to Day 7
Change from Baseline in Hematology Parameters
Time frame: Baseline to Day 7
Change from Baseline in Vital Signs
Time frame: Baseline to Day 7
Change from Baseline in Pulse Oximetry and Oxygen Delivery Measurements
Time frame: Baseline to Day 7
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Diagnosis of acute pancreatitis
- Predicted severe acute pancreatitis, based on protocol defined criteria
- Lack of clinically meaningful improvement from status at admission, at the discretion of Investigator, at the time of randomization
- Suitable for EUS-guided study drug administration procedure
- Contrast-enhanced computed tomography (CECT) or magnetic resonance imaging (MRI) of the abdomen/pancreas available for the evaluation of
Exclusion criteria
- Key Exclusion Criteria:
- Confirmed severe acute pancreatitis as defined by the Revised Atlanta Classification of Acute Pancreatitis (ie, Persistent \[\> 48 hours\] organ failure, per Modified Marshall Score), prior to randomization
- Anticipated discharge from hospital within 48 hours of randomization
- More than 30% pancreatic necrosis on screening CECT or MRI
- History of previous pancreatic necrosis, including necrosectomy
- History of calcific chronic pancreatitis
- Evidence of cholangitis
Where
- Little Rock, Arkansas
- Los Angeles, California
- Aurora, Colorado
- Gainesville, Florida
- Orlando, Florida
- Chicago, Illinois
- Indianapolis, Indiana
- Baltimore, Maryland
- Detroit, Michigan
- Lebanon, New Hampshire
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 28, 2026 · Source of record for eligibility and locations