This study 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-103. The approximately 208-day study consists of a Screening Period (28 days), Treatment Period (90 days), and Post-Dose Evaluations (90 days).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
Wake Research - Tucson
Tucson, Arizona, United States
RECRUITINGLong Beach Clinical Trials, Inc
Long Beach, California, United States
RECRUITINGRady Children's Hospital San Diego
San Diego, California, United States
RECRUITINGDiablo Clinical Research
Walnut Creek, California, United States
Safety
Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs), MedDRA 23.0 (CTCAE v. 5.0) or current
Time frame: Day 1 Through Day 180
Immune Safety
Serum Cytokines: IL-1β, TNF-α, IL-6, MCP-1, MIP-1α, IFN-γ, IL-4, IL-10
Time frame: Day 1 Through Day 180
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States
RECRUITINGUniversity of Florida
Gainesville, Florida, United States
RECRUITINGUniversity of Miami
Miami, Florida, United States
RECRUITINGDY Professional Research Center
Miami, Florida, United States
RECRUITINGUniversity of South Florida
Tampa, Florida, United States
RECRUITINGSouthern Illinois University School of Medicine
Springfield, Illinois, United States
RECRUITING...and 21 more locations