A Multiple Ascending Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0361-0041

Summary

The trial is a placebo-controlled, double-blinded within cohorts, randomized, multiple ascending dose trial with a sequential trial design. The primary outcome is to investigate the safety and tolerability of ascending subcutaneous weekly doses of NNC0361-0041 plasmid in patients with T1D.

Timeline

Start

2020-11-23

Primary completion

2023-08-31

Completion

2024-04-24

Publications

• Pang H, Chen Z, Han FY. Nano-based therapy for type 1 diabetes: from immuno-intervention to insulin delivery. Acta Biomater. 2025 Jul 1;201:101-120. doi: 10.1016/j.actbio.2025.06.016. Epub 2025 Jun 20.
• Pagni PP, Chaplin J, Wijaranakula M, Wesley JD, Granger J, Cracraft J, O'Brien C, Perdue N, Kumar V, Li S, Ratliff SS, Roach A, Misquith A, Chan CL, Coppieters K, von Herrath M. Multicomponent Plasmid Protects Mice From Spontaneous Autoimmune Diabetes. Diabetes. 2021 Aug 13:db210327. doi: 10.2337/db21-0327. Online ahead of print.
• Pagni PP, Chaplin J, Wijaranakula M, Wesley JD, Granger J, Cracraft J, O'Brien C, Perdue N, Kumar V, Li S, Ratliff SS, Roach A, Misquith A, Chan CL, Coppieters K, von Herrath M. Multicomponent Plasmid Protects Mice From Spontaneous Autoimmune Diabetes. Diabetes. 2021 Aug 13;71(1):157-69. doi: 10.2337/db21-0327. Online ahead of print.

Drugs

Indications