Clinical trial NCT03709342: A PK/PD Study of CM4620-IE in Patients With Acute Pancreatitis
Official title: A Pharmacodynamic and Pharmacokinetic Study of CM4620 Injectable Emulsion (CM4620-IE) in Patients With Acute Pancreatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Pancreatitis
Lead sponsor: CalciMedica, Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-17
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Exploratory: Percentage Change in IL-2 Production Relative to Pre-dose Values
timeFrame: Predose to 30 minutes post dose
Secondary outcomes:
measure: The Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: From baseline through 30 days
measure: Pharmacokinetics (CMax of CM4620): Day 1, 30 Minutes Post End-of-infusion
timeFrame: Days 1, 2, 5, 10 and 30 or at discharge if earlier than day 30
measure: Pharmacokinetics (Plasma Concentration of CM4620): Day 2, 20-hr Post End-of-infusion
timeFrame: Day 2
measure: Pharmacokinetics (Plasma Concentration of CM4620): Day 10 or Discharge
timeFrame: Day 10, or day of discharge
measure: Pharmacokinetics (Plasma Concentration of CM4620): Day 30
timeFrame: Day 30
measure: Baseline Levels of IL-6
timeFrame: Baseline
measure: Day 1: 30 Minutes Post-infusion IL-6 Levels
timeFrame: Day 1
measure: Day 2: 20-hr Post Infusion IL-6 Levels
timeFrame: Day 2
measure: Post-infusion IL-6 Levels at Discharge
timeFrame: Assessed at Discharge, between 2 and 9 days.
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
affiliation: CalciMedica, Inc.
name: Sudarshan Hebbar, MD
role: STUDY_DIRECTOR
References: