CNP-104 for Primary Biliary Cholangitis

Recruiting in Palo Alto (17 mi)

+21 other locations

Overseen byChristopher Bowlus, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: COUR Pharmaceutical Development Company, Inc.

Trial Summary

What is the purpose of this trial?This trial tests a new drug, CNP-104, in adults with a liver disease called primary biliary cholangitis. The drug is given through a vein to check its safety and effectiveness. The study will monitor patients for a period of time.

Eligibility Criteria

Adults aged 18-75 with Primary Biliary Cholangitis (PBC) unresponsive to standard treatments, having specific diagnostic factors like high alkaline phosphatase or positive PBC-specific antibodies. Participants must not be pregnant, agree to use effective contraception, and have liver function within certain limits. Excludes those with other liver diseases, history of organ transplant or severe cardiovascular events.

Inclusion Criteria

I have been on a stable dose of my PBC medication for at least 3 months.

Subjects who are willing and able to provide Institutional Review Board (IRB) approved written informed consent and privacy language as per national regulations

I am between 18 and 75 years old and not pregnant.

+6 more

Exclusion Criteria

I have an immune disorder or take drugs that weaken my immune system.

I have a liver condition such as hepatitis, Wilson's disease, or Gilbert's syndrome.

I have had cancer within the last 5 years.

+12 more

Participant Groups

The trial is testing CNP-104's safety and effectiveness in treating PBC compared to a placebo over a period of about two years. It involves multiple doses of the drug and monitors how well it works and its long-term effects on patients who haven't responded well to existing treatments.

3Treatment groups

Experimental Treatment

Placebo Group

Group I: 8 mg/Kg CNP-104Experimental Treatment1 Intervention

200 mL intravenous infusion on Day 1 and Day 8: 8 mg/Kg CNP-104

Group II: 4 mg/Kg CNP-104Experimental Treatment1 Intervention

200 mL intravenous infusion on Day 1 and Day 8: 4 mg/Kg CNP-104

Group III: PlaceboPlacebo Group1 Intervention

200 mL intravenous infusion on Day 1 and Day 8: Placebo