Overview

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

Status:
NOT_YET_RECRUITING

Trial end date:
2026-08-31

Target enrollment:

Participant gender:

Summary

Primary Objectives: To evaluate the safety and tolerability of a single dose of Exenatide Circular RNA-Lipid Nanoparticle InjectionCR059in Chinese subjects with T2DM. Secondary Objectives: * To characterize the pharmacokinetic (PK) profile of a single dose of Exenatide Circular RNA-Lipid Nanoparticle InjectionCR059 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

Phase:

EARLY_PHASE1

Details

Lead Sponsor:

The First Affiliated Hospital of Henan University of Science and Technology

Collaborator:

PegBio Co., Ltd.