Study of a Single Dose of Exenatide Circular RNA-Lipid Nanoparticle Injection CR059 to Assess Safety and Effects in Chinese Adults With Type 2 Diabetes

What this Trial Is About

Researchers are studying a new treatment called Exenatide Circular RNA-Lipid Nanoparticle Injection CR059 in Chinese adults with Type 2 Diabetes Mellitus T2DM. The study aims to assess the safety, tolerability, pharmacokinetics how the drug moves through the body, pharmacodynamics the drugs effects on the body, and immune response after a single dose of this treatment. Participants must have had T2DM for at least 3 months but less than 5 years, following Chinese diagnostic guidelines. The study is conducted at a single center and includes three groups receiving different single doses 4, 8, and 12 micrograms per kilogram. Each group will have 2 to 3 participants, totaling 6 to 9 subjects. After receiving one dose of CR059, participants will stay in the hospital for at least 7 days for observation and monitoring. Participants will undergo various assessments including monitoring for any treatment-related adverse events from the day of dosing until 36 days after. Blood tests will be taken to study the drugs behavior and immune response at multiple time points. The study will also measure how the drug affects the bodys functions over this period. Participants are expected to complete all study procedures and visits as scheduled during this follow-up period.

A Single-Center, Open-Label, Single Ascending Dose Study of Exenatide Circular RNA-Lipid Nanoparticle Injection (CR059) in Chinese Subjects With Type 2 Diabetes Mellitus