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.