CM4620 Injectable Emulsion Versus Supportive Care in Patients With Acute Pancreatitis and SIRS

PHASE2CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

March 12, 2018

Primary Completion Date

February 14, 2019

Study Completion Date

April 30, 2019

Conditions
Acute PancreatitisSystemic Inflammatory Response Syndrome
Interventions
DRUG

CM4620 Injectable Emulsion (Low Dose)

CM4620-IE 1.0 mg/kg on Day 1 and then 1.4 mg/kg on Days 2-4, during the first phase of the study (Cohorts 1 and 2). All doses of CM4620-IE will be administered intravenously (IV) over 4 hours.

DRUG

CM4620 Injectable Emulsion (High Dose)

CM4620-IE 2.08 mg/kg on Days 1 and 2 and then 1.6 mg/kg on Days 3 and 4, during the second phase of the study (Cohorts 3 and 4). All doses of CM4620-IE will be administered intravenously (IV) over 4 hours.

Trial Locations (9)

43214

Riverside Methodist, Columbus

44109

MetroHealth (Case Western), Cleveland

48201

Detroit Receiving Hospital (Wayne State), Detroit

48202

Henry Ford Hospital, Detroit

48235

Sinai-Grace Hospital (Wayne State), Detroit

55101

Regions Hospital, Saint Paul

55415

Hennepin County Medical Center, Minneapolis

63110

Washington University, St Louis

77030

Ben Taub (Baylor College of Medicine), Houston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

CalciMedica, Inc.

INDUSTRY