Phase 2
N=7
A PK/PD Study of CM4620-IE in Patients With Acute Pancreatitis
Acute Pancreatitis
Bottom Line
View on ClinicalTrials.gov: NCT03709342 ↗Enrolled (actual)
7
Serious AEs
14.3%
Results posted
May 2022
Primary outcome: Primary: Exploratory: Percentage Change in IL-2 Production Relative to Pre-dose Values — -55.5 percentage of change in IL-2 production
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CM4620-IE (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CalciMedica, Inc.
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Exploratory: Percentage Change in IL-2 Production Relative to Pre-dose Values |
-55.5 | — |
| SECONDARY The Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] |
3 | — |
| SECONDARY Pharmacokinetics (CMax of CM4620): Day 1, 30 Minutes Post End-of-infusion |
791 | — |
| SECONDARY Pharmacokinetics (Plasma Concentration of CM4620): Day 2, 20-hr Post End-of-infusion |
109 | — |
| SECONDARY Pharmacokinetics (Plasma Concentration of CM4620): Day 10 or Discharge |
76 | — |
| SECONDARY Pharmacokinetics (Plasma Concentration of CM4620): Day 30 |
56 | — |
| SECONDARY Baseline Levels of IL-6 |
46.04 | — |
| SECONDARY Day 1: 30 Minutes Post-infusion IL-6 Levels |
40.83 | — |
| SECONDARY Day 2: 20-hr Post Infusion IL-6 Levels |
24.8 | — |
| SECONDARY Post-infusion IL-6 Levels at Discharge |
13.9 | — |
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
- 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.
Data sourced from ClinicalTrials.gov (NCT03709342). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.