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

Inclusion criteria

• Diagnosis of acute pancreatitis established by the presence of abdominal pain consistent with acute pancreatitis, and 1 of the following 2 criteria:

• Serum lipase and/or serum amylase > 3 times the upper limit of normal (ULN);
• Characteristic findings of acute pancreatitis on abdominal imaging;
• Adults ≥ 18 years of age;
• 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;
• 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;
• 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

• 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;
• Suspected presence of cholangitis in the judgment of the treating investigator;
• Any malignancy being treated with chemotherapy or immunotherapy;
• Any autoimmune disease being treated with immunosuppressive medication or immunotherapy (Section 5.3 for list of prohibited medications);
• History of:

• Chronic pancreatitis, pancreatic necrosectomy, or pancreatic enzyme replacement therapy;
• Biopsy proven cirrhosis, portal hypertension, hepatic failure/hepatic encephalopathy;
• Known hepatitis B or C, or HIV;
• History of organ or hematologic transplant;
• Myocardial infarction, revascularization, cardiovascular accident (CVA) in the 30 days prior to Day 1;
• Current renal replacement therapy;
• Current known abuse of cocaine or methamphetamine;
• Known to be pregnant or are nursing;
• Participated in another study of an investigational drug or therapeutic medical device in the 30 days prior to Day 1;
• History of allergy to eggs or known hypersensitivity to any components of CM4620-IE;
• Prior treatment with CM4620-IE.