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Brief Title: Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of CNP-106 in Subjects With Myasthenia Gravis
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
Study ID: NCT06106672
Brief 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.
Detailed Description: This is a 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. The clinical study lasts 222-days (up to 42 days for Screening, 180 Study Days). Subjects ages 18-75 with generalized myasthenia gravis (MG) will be screened up to 42 days prior to enrollment into the clinical study.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Quantix Research, LLC, Miami, Florida, United States
University of South Florida, Tampa, Florida, United States
University of Kansas Medical Center, Kansas City, Kansas, United States
University of Minnesota, Minneapolis, Minnesota, United States
Ohio State University Wexner Medical Center, Columbus, Ohio, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Nerve and Muscle Center of Texas, Houston, Texas, United States
Virginia Commonwealth University, Richmond, Virginia, United States
Name: Roy First, MD
Affiliation: COUR Pharmaceutical
Role: STUDY_CHAIR