Testing Safety and Effects of CNP-103 in People Aged 12 to 35 with Recent Stage 3 Type 1 Diabetes

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacodynamics, and effectiveness of multiple increasing doses of CNP-103 in people aged 12 to 35 who have been recently diagnosed with Stage 3 Type 1 Diabetes within the past 6 months. This Phase 1b2a first-in-human clinical trial aims to better understand how CNP-103 works in this population and to assess any immune safety concerns. Participants receive three intravenous doses of CNP-103 at varying amounts 100 mg, 300 mg, or 600 mg on Days 1, 8, and 90. The study includes multiple groups, including adolescent and adult cohorts, with dosing for an expansion group determined based on initial results. A placebo containing 0.9% sodium chloride is also used for comparison. The trial follows a parallel design with random assignment and double masking. The study lasts approximately 393 days and consists of a 28-day screening period, a 90-day treatment period, and a 275-day post-dose evaluation phase. Participants will be monitored for safety and immune safety throughout the entire year. Various assessments will be conducted during visits to track the effects and tolerability of the study drug, with regular follow-up to evaluate long-term outcomes.

CNP-103 in Adolescent and Adult Subjects Ages 12-35 With Recently Diagnosed (Within 6 Months) Stage 3 Type 1 Diabetes (T1D)