RecruitingEarly Phase 1NCT07347080

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


Sponsor

The First Affiliated Hospital of Henan University of Science and Technology

Enrollment

9 participants

Start Date

Jan 20, 2026

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Exenatide Circular RNA-Lipid Nanoparticle Injection( CR059)) for people with t2dm. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGExenatide Circular RNA-Lipid Nanoparticle Injection( CR059))

use one dose per person


Locations(1)

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

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NCT07347080


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