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

CalciMedica

Status and phase: Completed; Phase 2

Conditions: Acute Pancreatitis

Treatments: Drug: CM4620-IE

Study type: Interventional

Funder types: Industry

Identifiers

NCT03709342

CM4620-202

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

All Patients

Experimental group

Treatment:

Drug: CM4620-IE