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NCT05104853 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Safety, Tolerability, PDs, and Efficacy of CNP-104 in Subjects With Primary Biliary Cholangitis
A Phase 1 study, sponsored by COUR Pharmaceutical Development Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
NCT05104853 is a Phase 1 study that has completed, run by COUR Pharmaceutical Development Company. The registered enrollment target is 42 participants.
The verdict
NCT05104853, a Phase 1 study, has completed, sponsored by COUR Pharmaceutical Development Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG CNP-104
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2022-01-25 |
| Est. Completion | 2026-01-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05104853
The ClinicalTrials.gov registry entry for NCT05104853 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is COUR Pharmaceutical Development Company, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05104853 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05104853 about?
NCT05104853 is a clinical study titled "Study to Evaluate the Safety, Tolerability, PDs, and Efficacy of CNP-104 in Subjects With Primary Biliary Cholangitis". 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 peri...
What is the current status of trial NCT05104853?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2022-01-25. Estimated completion is 2026-01-30.
What interventions are being tested in trial NCT05104853?
The interventions under investigation include: Placebo (DRUG), CNP-104 (DRUG).
Who is sponsoring clinical trial NCT05104853?
This trial is sponsored by COUR Pharmaceutical Development Company, which has 5 total clinical trials registered on ClinicalTrials.gov.
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