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RECRUITING
NCT06106672
PHASE1/PHASE2

Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of CNP-106 in Subjects With Myasthenia Gravis

Sponsor: COUR Pharmaceutical Development Company, Inc.

View on ClinicalTrials.gov

Summary

Phase 1b/2a First-in-Human (FIH) clinical trial to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of multiple ascending doses of CNP-106.

Official title: A Phase 1b/2a Double Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-106 in Subjects Ages 18-75 With Generalized Myasthenia Gravis

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

54

Start Date

2024-05-30

Completion Date

2026-08

Last Updated

2025-02-13

Healthy Volunteers

No

Interventions

DRUG

CNP-106

CNP-106 is comprised of an antigenic AChR Peptide Pool (\~1 μg of each AChRα and AChRε peptide comprising AChR Peptide Pool Drug Substance per mg particles) dispersed within a negatively charged (-30 to -60 mV) polymer matrix of PLGA (Poly (DL-lactide-co-glycolide, 50:50 acid-end group)) particles (400-800 nm in size).

OTHER

Placebo

CNP-106 Placebo

Locations (17)

Barrow Neurological Institute

Phoenix, Arizona, United States

Neuromuscular Clinic and Research Center

Phoenix, Arizona, United States

Infusion for Health

Brea, California, United States

University of California, Irvine

Orange, California, United States

Yale University

New Haven, Connecticut, United States

Atlantis Research

Miami, Florida, United States

Quantix Research, LLC

Miami, Florida, United States

University of South Florida

Tampa, Florida, United States

Insight Hospital and Medical Center

Chicago, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Insight Research Institute, Dearborn

Dearborn, Michigan, United States

University of Missouri, NextGen Precision Health

Columbia, Missouri, United States

Ohio State University Wexner Medical Center

Colombus, Ohio, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Nerve and Muscle Center of Texas

Houston, Texas, United States

Prolato Clinical Research Center

Houston, Texas, United States

Virginia Commonwealth University

Richmond, Virginia, United States