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

NCT03709342 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CM4620-202
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pancreatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• The Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  From baseline through 30 days

• 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

• Pharmacokinetics (Plasma Concentration of CM4620): Day 2, 20-hr Post End-of-infusion

  Day 2

• Pharmacokinetics (Plasma Concentration of CM4620): Day 10 or Discharge

  Day 10, or day of discharge

• Pharmacokinetics (Plasma Concentration of CM4620): Day 30

  Day 30

Study Arms (1)

All Patients

EXPERIMENTAL

Drug: CM4620-IE

Interventions

CM4620-IE DRUG

single IV infusion on Day 1 over 4 hours

All Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• CalciMedica, Inc.: lead

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Results Point of Contact

• Title: Sudarshan Hebbar, MD
• Organization: CalciMedica

sudarshan@calcimedica.com

816-838-7105

Study Officials

• Sudarshan Hebbar, MD

  CalciMedica, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 17, 2018
• Study Start: January 6, 2019
• Primary Completion: March 7, 2019
• Study Completion: June 7, 2019
• Last Updated: May 3, 2022
• Results First Posted: May 3, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)