216
Participants
Start Date
March 24, 2021
Primary Completion Date
May 15, 2024
Study Completion Date
May 15, 2024
CM-4620 Injectable Emulsion or CM-4620-IE
Auxora is to be administered as an IV infusion and is supplied as a translucent, white to yellowish colored, sterile, non-pyrogenic emulsion containing 1.6 mg/mL of the active pharmaceutical ingredient CM4620. CM4620-IE is supplied as an 80 mL fill in a 100 mL, single-use glass vial. The drug product is formulated as an emulsion due to the low solubility of CM4620 in aqueous solution. CM4620-IE contains egg phospholipids, medium chain triglycerides, glycerin, edetate disodium salt dehydrate (EDTA), sodium hydroxide (as needed to adjust pH), and sterile water for injection.
Placebo
Matching Placebo is to be administered as an IV infusion and is supplied as a translucent, white to yellowish, sterile, non-pyrogenic emulsion carrier containing no active pharmaceutical ingredient. Placebo is supplied as an 80 mL fill in a 100 mL single-use vial. Placebo contains the same ingredients as Auxora except that it does not contain CM4620.
Icahn School of Medicine at Mount Sinai, New York
Northshore University Hospital, Manhasset
University of Maryland, Baltimore
University of Virginia, Charlottesville
CAMC Institute for Academic Medicine, Charleston
Tampa General Hospital, Tampa
Sarasota Memorial Health Care System, Sarasota
Regional One Health, Memphis
Robley Rex VA Medical Center, Louisville
Ohio State University, Columbus
Henry Ford Health System, Detroit
Regions Hospital, Saint Paul
Methodist Hospital, Saint Louis Park
Northwestern University Hospital, Chicago
Washington University School of Medicine, St Louis
University of Missouri School of Medicine, Columbia
John Peter Smith Hospital, Fort Worth
Houston Methodist Hospital, Houston
UT Health Houston, Houston
St. Luke's Regional Medical Center, Boise
LA County Hospital - USC, Los Angeles
Cedars Sinai, Los Angeles
Harbor UCLA Medical Center, Torrance
Torrance Memorial Medical Center, Torrance
Long Beach Medical Center, Long Beach
University of California at Irvine Medical Center, Orange
The Stamford Hospital, Stamford
SPMC, Bīkaner
PGIMER, Chandigarh, Chandigarh
Malla Reddy Narayana, Hyderabad
MDM Hospital, Jodhpur
Lisie Hospital, Kochi
Seven Star Hospital, Nagpur
JIPMER, Puducherry
MTES' Sanjeevan Hospital, Pune
Shree Giriraj Multispeciality Hospital, Rajkot
IGMU (India Gandhi Medical), Shimla
Lead Sponsor
CalciMedica, Inc.
INDUSTRY