Actively Recruiting
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
Led by The First Affiliated Hospital of Henan University of Science and Technology · Updated on 2026-04-06
9
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital of Henan University of Science and Technology
Lead Sponsor
P
PegBio Co., Ltd.
Collaborating Sponsor
AI-Summary
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 drug's 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 drug's behavior and immune response at multiple time points. The study will also measure how the drug affects the body’s functions over this period. Participants are expected to complete all study procedures and visits as scheduled during this follow-up period.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Chinese male or female, aged 18 to 65 years
- Diagnosed with Type 2 Diabetes Mellitus for at least 3 months but less than 5 years according to Chinese diagnostic criteria
- Have not achieved blood sugar control with diet and exercise alone, metformin only, or a stable regimen of metformin combined with certain specified oral antidiabetic drugs for at least 12 weeks
- Fasting plasma glucose less than 13.0 mmol/L and HbA1c between 7.5% and 10.0%
- Body Mass Index (BMI) between 18.5 and 40.0 kg/m² at screening and enrollment
- No pregnancy plans during the study and willing to use effective contraception until 3 months after last dose
- Able to understand and willingly sign informed consent
- Able to complete the study according to protocol requirements
You will not qualify if you...
- Diagnosis of type 1 diabetes, diabetes due to pancreatic injury, or other specific diabetes types
- Recent acute diabetic complications such as ketoacidosis or hyperosmolar coma within 6 months
- Severe chronic diabetic complications within 6 months deemed unsuitable for participation
- Allergy to multiple drugs or foods, or history of drug allergy or potential allergy to the study drug
- Low fasting plasma glucose (<3.9 mmol/L) or history of severe or frequent hypoglycemia within 6 months
- Presence of certain hormone-related diseases or obesity due to hormonal causes
- Recent use of weight-control medications, weight-loss surgery, or significant weight changes
- Abnormal thyroid function or history of thyroid diseases deemed unsuitable
- Personal or family history of certain endocrine cancers or thyroid nodules
- History or presence of malignant tumors except certain cured skin or cervical cancers
- History of blood clotting or bleeding disorders, recent thrombotic events, or abnormal coagulation
- Use of anticoagulants or antiplatelet drugs long-term or currently
- Significant cardiovascular or cerebrovascular diseases within 6 months
- Recent history of gout or gout attacks
- Uncontrolled high blood pressure or unstable antihypertensive treatment
- Abnormal resting heart rate or ECG findings
- Significant respiratory diseases excluding sleep apnea
- Severe gastrointestinal diseases or surgeries affecting the digestive system
- Severe kidney disease or low kidney function
- Elevated pancreatic enzymes or history of pancreatitis
- History of gallbladder diseases unless fully treated
- Severe lipid disorders unless stable on treatment
- History of psychiatric disorders within 2 years
- Recent major surgery, infection, or inflammation
- Recent blood donation or transfusion
- Certain abnormal lab values including liver enzymes, bilirubin, calcitonin, blood counts
- Recent use of weight-affecting drugs including certain antidepressants and antipsychotics
- Recent use of specific diabetes-related receptor agonists within 6 months
- History of bariatric surgery except certain cosmetic procedures
- Participation in other clinical trials within 3 months
- Positive tests for hepatitis B, hepatitis C, syphilis, or HIV
- Recent drug abuse or alcoholism
- Positive drug or alcohol tests at screening
- Pregnant or breastfeeding women, or those using oral contraceptives
- Intolerance to blood draws or history of fainting from needles
- Any other condition deemed unsuitable for participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 7 days
Participants receive a single dose of the study drug and are observed in-hospital for safety and tolerability.
Continuous in-hospital observation for at least 7 days
Duration - Up to Day 36 after dosing
Participants are monitored for safety, pharmacokinetics, pharmacodynamics, and immunogenicity after treatment.
Visits on Day 15 and Day 29 plus additional assessments until Day 36
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China, 310015
Actively Recruiting
Research Team
H
Hongwei Jiang, PhD Supervisor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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