Recruiting
Phase 2

RABI-767

Sponsor:

Panafina, Inc.

Code:

NCT06080789

Conditions

Acute Pancreatitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

RABI-767

Study Details

Brief 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.

Conditions

Acute Pancreatitis

Study ID

NCT06080789

Start date

Jun 28, 2024

Status verified date

Aug, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Key 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

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: RABI-767 plus Standard-of-Care

Single-dose 125 mg RABI-767 plus standard-of-care

no intervention: Standard-of-Care Only

No Intervention, Standard-of-Care Only

Interventions

RABI-767

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

Primary outcome measure

  • Number of Participants with Adverse Events [ Time Frame: Enrollment/Randomization to Day 28 (or hospital discharge, if earlier) ]
  • Number of Participants with Serious Adverse Events [ Time Frame: Enrollment/Randomization to Day 35 Follow-up ]
  • 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 ]

Central Contacts and Locations

Central contacts

Kelly Abernathy

9194609500kabernathy@arrivobio.com

Locations

University of Arkansas for Medical Sciences

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Clinical Research Coordinator

501-526-4860

Keck Hospital of USC and LA County Hospital

Recruiting

Los Angeles, California, United States, 90033

Contacts

323-409-6939

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Clinical Research Coordinator

303-724-1871

University of Florida Health

Recruiting

Gainesville, Florida, United States, 32608

Contacts

Clinical Research Coordinator

352-273-9483

Orlando Health

Recruiting

Orlando, Florida, United States, 32806

Contacts

Clinical Research Coordinator

321-841-6649

UI Health, University of Illinois Chicago Hospital Health Sciences System

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Clinical Research Coordinator

630-518-5456

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Clinical Research Coordinator

410-614-6708

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Clinical Research Coordinator

313-746-8215

Dartmouth Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Clinical Research Coordinator

603-653-3651

NYU Langone Medical Center

Recruiting

New York, New York, United States, 10016

Contacts

Clinical Research Coordinator

212-263-3095

More Information

Sponsor

Panafina, Inc.

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Panafina, Inc. on 2026-08-05.