A Study to Evaluate the Safety and Efficacy of a Single Dose of RABI-767 in Participants With Acute Pancreatitis
NCT06080789 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2026-04-03
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
Interventions
- DRUG
-
RABI-767
125 mg single-dose given by endoscopic-ultrasound (EUS) guided peripancreatic injection.
Sponsors & Collaborators
-
Panafina, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-28
- Primary Completion
- 2026-11-30
- Completion
- 2026-11-30
- FDA Drug
- Yes
Countries
- United States
- India
Study Locations
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