NCT07347080

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

A Single-Center, Open-Label, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Exenatide Circular RNA-Lipid Nanoparticle Injection (CR059) in Chinese Subjects With Type 2 Diabetes Mellitus

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: The First Affiliated Hospital of Henan University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Primary Objectives: •To evaluate the safety and tolerability of a single dose of Exenatide Circular RNA-Lipid Nanoparticle Injection（CR059）in Chinese subjects with T2DM. Secondary Objectives: * To characterize the pharmacokinetic (PK) profile of a single dose of Exenatide Circular RNA-Lipid Nanoparticle Injection（CR059） in Chinese subjects with T2DM; * To characterize the pharmacodynamic (PD) profile of a single dose of Exenatide Circular RNA-Lipid Nanoparticle Injection（ CR059） in Chinese subjects with T2DM; * To evaluate the immunogenicity of a single dose of Exenatide Circular RNA-Lipid Nanoparticle Injection（ CR059） in Chinese subjects with T2DM; Participants : Diagnosed with T2DM for at least 3 months but less than 5 years, according to the Chinese Diabetes Society's diagnostic criteria

Detailed description

This is a single-center, open-label, single ascending dose study designed to evaluate the safety, tolerability, PK, PD, and immunogenicity of Exenatide Circular RNA-Lipid Nanoparticle Injection（ CR059）in Chinese subjects with T2DM. It is planned to enroll 6-9 subjects.The study includes three dose cohorts (low, medium, high: 4 μg/kg, 8 μg/kg, 12 μg/kg). Each cohort plans to enroll 2-3 T2DM subjects. A single dose will be administered, with subjects observed in-hospital for at least 7 days.

Conditions

• T2DM

Interventions

Type	Name	Description
DRUG	Exenatide Circular RNA-Lipid Nanoparticle Injection（ CR059））	use one dose per person

Timeline

• Start date: 2026-01-20
• Primary completion: 2026-08-31
• Completion: 2026-08-31
• First posted: 2026-01-16
• Last updated: 2026-04-06

Locations

1 site across 1 country: China