drugset / Trial / NCT06783309

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

NCT06783309 ↗

Phase 1/2 Recruiting 72 enrolled COUR Pharmaceutical Development Company, Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

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 393-days study consists of a Screening Period (28 days), Treatment Period (90 days), and Post-Dose Evaluations (275 days).

Timeline

Start
2025-05-12
Primary completion
2026-12
Completion
2027-06

Drugs

EvaluationDrugModalityDoseRoute
Subject CNP-103 Unknown 100 mg Intravenous
Subject CNP-103 Unknown 300 mg Intravenous
Subject CNP-103 Unknown 600 mg Intravenous