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

Acute Pancreatitis Clinical Trial

Official title:

A Pharmacodynamic and Pharmacokinetic Study of CM4620 Injectable Emulsion (CM4620-IE) in Patients With Acute Pancreatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03709342
• Other study ID #: CM4620-202
• Status: Completed
• Phase: Phase 2
• Start date: January 6, 2019
• Est. completion date: June 7, 2019

Study information

• Verified date: February 2022
• Source: CalciMedica, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: June 7, 2019
• Est. primary completion date: March 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Intervention

Drug:
• CM4620-IE
single IV infusion on Day 1 over 4 hours

Locations

Country	Name	City	State
United States	Henry Ford Hospital	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
CalciMedica, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exploratory: Percentage Change in IL-2 Production Relative to Pre-dose Values	Outcome assessed the percent change in IL-2 production after the administration of a single dose of CM4620-IE as compared to baseline production, for all patients enrolled. This measurement was to explore if there was a change in IL-2 levels with acute pancreatitis after the administration of a single dose of CM4620-IE.	Predose to 30 minutes post dose
Secondary	The Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	The number of participants who experienced treatment-emergent adverse events (TEAEs) with Investigator-specified relationship to CM4620-IE and assessment of severity.	From baseline through 30 days
Secondary	Pharmacokinetics (CMax of CM4620): Day 1, 30 Minutes Post End-of-infusion		Days 1, 2, 5, 10 and 30 or at discharge if earlier than day 30
Secondary	Pharmacokinetics (Plasma Concentration of CM4620): Day 2, 20-hr Post End-of-infusion	Time points for sampling of plasma for bioanalysis of CM4620, blood for PD analysis (stimulated IL-2 release), and serum for cytokine analysis were chosen to capture the expected maximal plasma concentration (Cmax) on Day 1 and times close to the minimum plasma concentration (Cmin) on subsequent days.	Day 2
Secondary	Pharmacokinetics (Plasma Concentration of CM4620): Day 10 or Discharge		Day 10, or day of discharge
Secondary	Pharmacokinetics (Plasma Concentration of CM4620): Day 30		Day 30
Secondary	Baseline Levels of IL-6	Included plasma samples collected 1 hour prior to the study drug administration	Baseline
Secondary	Day 1: 30 Minutes Post-infusion IL-6 Levels		Day 1
Secondary	Day 2: 20-hr Post Infusion IL-6 Levels		Day 2
Secondary	Post-infusion IL-6 Levels at Discharge	This sample was drawn immediately prior to discharge from hospitalization, and ranged from day 2 through day 9.	Assessed at Discharge, between 2 and 9 days.