A PK/PD Study of CM4620-IE in Patients With Acute Pancreatitis
Condition: Acute Pancreatitis
MeSH terms: Pancreatitis
Intervention: CM4620-IE
Intervention description: single IV infusion on Day 1 over 4 hours
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label study will evaluate the pharmacodynamic and pharmacokinetic profile of
      CM4620-IE in patients with acute pancreatitis. The first five (5) patients will receive ≤
      2.08 mg/kg of CM4620-IE by continuous IV infusion on Day 1. If necessary, up to an additional
      4 patients may be treated at a different dose of CM4620-IE as determined by the obtained PK
      and PD data. The infusion of CM4620-IE will start within 12 hours from the time the patient
      or LAR provides informed consent.
    

Eligibility criteria:

        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.