NCT05104853 - Study to Evaluate the Safety, Tolerability, PDs, and Efficacy of CNP-104 in Subjects with Primary Biliary Cholangitis | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 25, 2022

Primary Completion Date

January 30, 2026

Study Completion Date

January 30, 2026

Conditions

Primary Biliary Cholangitis

Interventions

DRUG

CNP-104

CNP-104 is comprised of PDC-E2 peptide dispersed within a negatively charged polymer matrix of poly (lactic-co-glycolic acid) (PLGA) particles at a target concentration of \~1 μg of PDC-E2 peptide per mg of PLGA particles.

DRUG

Placebo

CNP-104 Placebo

Trial Locations (19)

10467

Montefiore Medical Center, The Bronx

22903

University of Virginia, Charlottesville

27710

Duke University Medical Center, Durham

30309

Digestive Healthcare of Georgia, Atlanta

32224

Mayo Clinic Florida, Jacksonville

32610

University of Florida - Hepatology Research, Gainesville

33331

Cleveland Clinic - Florida, Weston

34102

GI PROS Research, Naples

48377

Henry Ford Health System, Novi

60637

University of Chicago Medical Center, Chicago

63110

Washington University School of Medicine in St. Louis, St Louis

78215

Texas Liver Institute, San Antonio

80907

Peak Gastroenterology Associates, Colorado Springs

92118

Southern California Research Center, Coronado

93534

OM Research, Lancaster

95817

University of California Davis Health, Sacramento

06520

Yale School of Medicine, New Haven

34211-4930

Florida Research Institute, Lakewood Rch

02114

Massachusetts General Hospital, Boston