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Clinical trialNCT05104853CompletedPhase 1/PHASE2Interventional

Study to Evaluate the Safety, Tolerability, PDs, and Efficacy of CNP-104 in Subjects With Primary Biliary Cholangitis

SponsorCOUR Pharmaceutical Development Company, Inc.Enrollment42Primary Biliary Cholangitis
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This study is a Phase 2a First-in-Human (FIH) clinical trial to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of multiple ascending doses of CNP-104. The study consists of a 120 day primary study followed by a 20 month long-term safety and durability of response follow-up period.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

19 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Southern California Research Center

    Coronado, California, United States

  • Om Research

    Lancaster, California, United States

  • University of California Davis Health

    Sacramento, California, United States

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, United States

  • Yale School of Medicine

    New Haven, Connecticut, United States

  • University of Florida - Hepatology Research

    Gainesville, Florida, United States

  • Mayo Clinic Florida

    Jacksonville, Florida, United States

  • Florida Research Institute

    Lakewood Rch, Florida, United States

  • Gi Pros Research

    Naples, Florida, United States

  • Cleveland Clinic - Florida

    Weston, Florida, United States

  • Digestive Healthcare of Georgia

    Atlanta, Georgia, United States

  • University of Chicago Medical Center

    Chicago, Illinois, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, United States

  • Henry Ford Health System

    Novi, Michigan, United States

  • Washington University School of Medicine in St. Louis

    St Louis, Missouri, United States

  • Montefiore Medical Center

    The Bronx, New York, United States

  • Duke University Medical Center

    Durham, North Carolina, United States

  • Texas Liver Institute

    San Antonio, Texas, United States

  • University of Virginia

    Charlottesville, Virginia, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

CNP-104Placebo
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
25 Jan 2022
Primary completion
30 Jan 2026
Completion
30 Jan 2026
Last update posted
10 Mar 2026
Registered enrollment
42
Registry id
NCT05104853

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.