A PK/PD Study of CM4620-IE in Patients With Acute Pancreatitis

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. Adults ≥ 18 years of age; 3. 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; 4. 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; 5. Willing and able to, or have a legal authorized representative (LAR) who is willing and able to, provide informed consent to participate, and 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 or may limit expected survival to \< 6 months; 2. Suspected presence of cholangitis in the judgment of the treating investigator; 3. Any malignancy being treated with chemotherapy or immunotherapy; 4. Any autoimmune disease being treated with immunosuppressive medication or immunotherapy (Section 5.3 for list of prohibited medications); 5. History of: 1. Chronic pancreatitis, pancreatic necrosectomy, or pancreatic enzyme replacement therapy; 2. Biopsy proven cirrhosis, portal hypertension, hepatic failure/hepatic encephalopathy; 3. Known hepatitis B or C, or HIV; 4. History of organ or hematologic transplant; 5. Myocardial infarction, revascularization, cardiovascular accident (CVA) in the 30 days prior to Day 1; 6. Current renal replacement therapy; 7. Current known abuse of cocaine or methamphetamine; 8. Known to be pregnant or are nursing; 9. Participated in another study of an investigational drug or therapeutic medical device in the 30 days prior to Day 1; 10. History of allergy to eggs or known hypersensitivity to any components of CM4620-IE; 11. Prior treatment with CM4620-IE.