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

Phase 1/2 Completed 42 enrolled COUR Pharmaceutical Development Company, Inc.

RandomizedSequentialDouble-blindTreatment

Summary

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.

Timeline

Start: 2022-01-25
Primary completion: 2026-01-30
Completion: 2026-01-30

Publications

Klatzkow H, Bhavsar-Burke I, Pearson M, Wentworth BJ. Primary Biliary Cholangitis in 2025: A New Frontier. Am J Gastroenterol. 2025 Dec 1;120(12):2746-2749. doi: 10.14309/ajg.0000000000003559. Epub 2025 May 29. No abstract available.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CNP-104	Unknown	4 mg/kg	Intravenous
Subject	CNP-104	Unknown	8 mg/kg	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications