CM4620 Injectable Emulsion Versus Supportive Care in Patients With Acute Pancreatitis and SIRS

Inclusion Criteria: 1. Diagnosis of acute pancreatitis established by the presence of abdominal pain consistent with acute pancreatitis and 1 of the following 2 criteria: 1. Serum lipase and/or serum amylase \> 3 times the upper limit of normal (ULN); 2. Characteristic findings of acute pancreatitis on abdominal imaging; 2. A SpO2 \<96% with a FiO2 of 21% (room air) to 27%, or a SpO2 \<97% with a FiO2 ≥28%; 3. Diagnosis of SIRS, defined by the presence of at least 2 of the following 4 criteria: 1. Temperature \< 36°C or \> 38°C; 2. Heart rate \> 90 beats/minute; 3. Respiratory rate \>20 breaths/minute or arterial carbon dioxide tension (PaCO2) \<32 mmHg; 4. White blood cell count (WBC) \>12,000 mm3, or \<4,000 mm3, or \> 10% immature (band) forms; 4. No evidence of pancreatic necrosis on contrast-enhanced computed tomography (CECT performed in the 18 hours prior to consent or after consent and before Day 1; 5. Adults ≥ 18 years of age; 6. A female patient of child bearing potential who is sexually active with a male partner must be willing to practice acceptable methods of birth control for 365 days after the last dose of CM4620-IE; 7. A male patient who is sexually active with a female partner of childbearing potential must be willing to practice acceptable methods of birth control for 365 days after the last dose of CM4620-IE and must not donate sperm for 365 days. 8. Willing and able to, or have a legal authorized representative (LAR) that is willing and able to, provide informed consent to participate, and to cooperate with all aspects of the protocol. Exclusion Criteria: 1. Any concurrent clinical condition that a study physician believes could potentially pose an unacceptable health risk to the patient while involved in the study, including a CV SOFA score of 4 at the time of screening, or may limit expected survival to \<6 months; 2. Suspected presence of cholangitis in the judgment of the treating investigator; 3. ERCP performed in the previous 7 days; 4. Any malignancy being treated with chemotherapy or immunotherapy; 5. Any autoimmune disease being treated with immunosuppressive medication or immunotherapy; 6. History of: 1. Acute pancreatitis with pancreatic necrosis on Contrast-Enhanced Computed Tomography (CECT) of the pancreas; 2. Chronic pancreatitis, pancreatic necrosis or necrosectomy, or pancreatic enzyme replacement therapy; 3. Biopsy proven cirrhosis, portal hypertension, hepatic failure/hepatic encephalopathy; 4. Known hepatitis B or C, or HIV; 5. History of organ or hematologic transplant; 6. Resuscitated cardiac arrest, myocardial infarction, revascularization, cardiovascular accident (CVA) in the 30 days prior to Day 1; 7. Current renal replacement therapy; 8. Current known abuse of cocaine or methamphetamine; 9. Known to be pregnant or are nursing; 10. Participated in another study of an investigational drug or therapeutic medical device in the 30 days prior to Day 1; 11. History of allergy to eggs or known hypersensitivity to any components of CM4620-IE.