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

NCT03709342 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2022-05-03

Study results available
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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

Interventions

DRUG

CM4620-IE

single IV infusion on Day 1 over 4 hours

Sponsors & Collaborators

  • CalciMedica, Inc.

    lead INDUSTRY

Principal Investigators

  • Sudarshan Hebbar, MD · CalciMedica, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-06
Primary Completion
2019-03-07
Completion
2019-06-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03709342 on ClinicalTrials.gov