Back to resultsA PK/PD Study of CM4620-IE in Patients With Acute Pancreatitis
Primary Purpose
Acute Pancreatitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CM4620-IE
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pancreatitis
Eligibility Criteria
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.
Sites / Locations
- Henry Ford Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All Patients
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Pharmacokinetics (CMax of CM4620): Day 1, 30 Minutes Post End-of-infusion
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.
Pharmacokinetics (Plasma Concentration of CM4620): Day 10 or Discharge
Pharmacokinetics (Plasma Concentration of CM4620): Day 30
Baseline Levels of IL-6
Included plasma samples collected 1 hour prior to the study drug administration
Day 1: 30 Minutes Post-infusion IL-6 Levels
Day 2: 20-hr Post Infusion IL-6 Levels
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03709342
Brief Title
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
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 6, 2019 (Actual)
Primary Completion Date
March 7, 2019 (Actual)
Study Completion Date
June 7, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CalciMedica, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pancreatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
All Patients
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CM4620-IE
Intervention Description
single IV infusion on Day 1 over 4 hours
Primary Outcome Measure Information:
Title
Exploratory: Percentage Change in IL-2 Production Relative to Pre-dose Values
Description
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.
Time Frame
Predose to 30 minutes post dose
Secondary Outcome Measure Information:
Title
The Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
The number of participants who experienced treatment-emergent adverse events (TEAEs) with Investigator-specified relationship to CM4620-IE and assessment of severity.
Time Frame
From baseline through 30 days
Title
Pharmacokinetics (CMax of CM4620): Day 1, 30 Minutes Post End-of-infusion
Time Frame
Days 1, 2, 5, 10 and 30 or at discharge if earlier than day 30
Title
Pharmacokinetics (Plasma Concentration of CM4620): Day 2, 20-hr Post End-of-infusion
Description
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.
Time Frame
Day 2
Title
Pharmacokinetics (Plasma Concentration of CM4620): Day 10 or Discharge
Time Frame
Day 10, or day of discharge
Title
Pharmacokinetics (Plasma Concentration of CM4620): Day 30
Time Frame
Day 30
Title
Baseline Levels of IL-6
Description
Included plasma samples collected 1 hour prior to the study drug administration
Time Frame
Baseline
Title
Day 1: 30 Minutes Post-infusion IL-6 Levels
Time Frame
Day 1
Title
Day 2: 20-hr Post Infusion IL-6 Levels
Time Frame
Day 2
Title
Post-infusion IL-6 Levels at Discharge
Description
This sample was drawn immediately prior to discharge from hospitalization, and ranged from day 2 through day 9.
Time Frame
Assessed at Discharge, between 2 and 9 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sudarshan Hebbar, MD
Organizational Affiliation
CalciMedica, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A PK/PD Study of CM4620-IE in Patients With Acute Pancreatitis
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