Chronic wounds that do not improve significantly with standard treatment (diabetic foot ulcers, burn residual wounds, etc.)
Conditions
Interventions
Cohort 1:Single dose - trial drug intervention - 20ug/ml
Cohort 2:Single dose - placebo - 20ug/ml
Cohort 3:Single dose - trial drug intervention - 40ug/ml
Cohort 4:Single dose - placebo - 40ug/ml
Cohort 5:Single dose - trial drug intervention - 60ug/ml
Cohort 6:Single dose - placebo - 60ug/ml
Cohort 7:Multiple doses - trial drug intervention - 20ug/ml
Cohort 8:Multiple doses - placebo - 20ug/ml
Cohort 9:Multiple doses - trial drug intervention - 40ug/ml
Cohort 10:Multiple doses - placebo - 40ug/ml
Cohort 11:Multiple doses - trial drug intervention - 60ug/ml
Cohort 12:Multiple doses - placebo - 06ug/ml
Sponsors
The Affiliated Hospital of Jiangnan University/The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Those who understand the research procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing; 2. Age = 18 years old and = 80 years old on the day of signing the informed consent form, male or female; 3. Chronic wound diagnosis (diabetic foot ulcer, burn residual wound, etc.); Chronic wounds are those that have existed for 4 weeks or more before randomization, and the wound has not improved significantly or continued to expand as judged by the investigator. 4. Before randomization, the study wound was neat and there was granulation tissue at the base, and the wound area was 2~25 cm^2 (including the boundary value). 5. There was no active infection in the study wound; 6 Diabetic foot ulcers must meet the following criteria: 1) Wagner ulcers are graded as grades 1 and 2 (see Annex 1); or Wagner grade 3 ulcer was initially diagnosed, infection control after treatment, and granulation tissue appeared at the base, and skin grafting was not required after the investigator's assessment; 2) Ankle-brachial index (ABI) >= 0.6 and = 30 mmHg. 7. Good organ and bone marrow function, laboratory test results within 14 days before the first dose meet the following criteria: 1) Hemoglobin >= 90 g/L; 2) Platelet >=100×10^9/L; 3) White blood cell (WBC) >= 3.0×10^9/L and <= 12.0×10^9/L (or judged by the investigator according to the patient's condition); 4) alanine aminotransferase (ALT) or aspartate aminotransferase (AST) <=2.5×ULN; 5) Serum creatinine (Cr) <=1.5×ULN; 6) Fasting blood glucose<=10 mmol/L 7) Glycosylated hemoglobin A1c (HbA1c) <=12.0%; 8) Coagulation routine: international normalized ratio (INR) <= 1.5×ULN, activated partial thromboplastin time (APTT) <=1.5×ULN; 9) ECG: QTcF<480ms. 8. Female subjects of childbearing potential must agree to use effective contraception and refrain from egg donation for 6 months after the last dose of the experimental drug from the time of signing the informed consent form until 6 months after the last dose of the investigational drug, and the serum pregnancy test must be negative within 7 days before the first dose, and they must not be lactating; Male subjects whose partner is a woman of childbearing potential must agree to highly effective contraception and refrain from sperm donation from the time of signing the informed consent form until 6 months after the last dose of the investigational drug
Exclusion criteria
Exclusion criteria: 1 Presence of gangrene, suppuration, or sinus tract in the wound that cannot be removed by debridement; 2 Presence of osteomyelitis at the wound site; 3 Presence of the following diseases or treatment history: 1) Patients with previous diagnosis of proliferative diabetic retinopathy or other proliferative retinopathy, or unable to undergo retinal examination; 2) Have a history of malignant tumors in the past, or have abnormal results of any of the following examinations at screening, and have tumor risk as judged by the investigator: a) Chest X-ray or chest CT examination; b) alpha-fetoprotein (AFP); c) Carcinoembryonic antigen (CEA); d) carbohydrate antigen CA19-9 (CA19-9); e) Carbohydrate antigen CA125 (CA125), female subjects only; f) Prostate-specific antigen (PSA), male subjects only; g) Mammography/ultrasonography for female subjects only; 3) Have previously used gene cell therapy (including plasmid DNA, RNA, genetically modified viruses, bacteria or cells, and products based on gene editing technology, etc.) or participated in clinical trials related to gene and cell therapy; 4) Cardiac function grade III-IV as defined by the New York Heart Association (NYHA) at screening or randomization (see Annex 2 for grading criteria); 5) Previous connective tissue diseases, including lupus erythematosus, rheumatoid arthritis, scleroderma, etc.; 6) Refractory hypertension (systolic blood pressure >= 180 mmHg or diastolic blood pressure >= 110 mmHg after adequate antihypertensive therapy); 7) Acute cardiovascular and cerebrovascular diseases within 90 days before screening, including but not limited to cerebral infarction (except lacunar cerebral infarction), cerebral hemorrhage, myocardial infarction, unstable angina, severe arrhythmia, etc.; 8) Presence of severe liver disease, including but not limited to liver cirrhosis with jaundice, ascites, etc.; 9) History of major surgery within 90 days prior to screening or planned major surgery during the study; Note: Major surgery refers to surgery that may pose a direct threat to the patient's life or vital organs or risk of damage and has a poor prognosis. 10) Participated in other drug clinical trials within 90 days before screening (except for those who failed screening), or within 5 half-lives of drugs at the time of randomization (whichever is longer); 11) Suspected history of allergy to the investigational drug or any ingredient in the investigational drug; 12) Previous drug abuse or drug abuse; 13) Known human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) infection, active hepatitis C virus (HCV) infection, or active tuberculosis and other infectious diseases, which are judged by the investigator to be unsuitable for participating in clinical trials; a) Active HBV infection: positive for hepatitis B surface antigen (HbsAg) at screening and HBV-DNA viral load greater than the upper limit of the normal reference range of local medical institutions; b) Active HCV infection: both HCV antibody test results and HCV-RNA test results are positive at screening. 4 General conditions: 1) Those who are unable to correctly describe symptoms and emotions; 2) The investigator judges that the subject has poor compliance or has any inappropriate participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post-dose adverse events (AEs) incidence ;Post-dose adverse events (AEs) severity; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK parameters of external RGL-2102 mRNA in peripheral blood after administration;PK parameters of hepatocyte growth factor protein in peripheral blood after administration;PK parameters of lipids in peripheral blood after dosing; | — |
Countries
China
Contacts
Public ContactLv Guozhong/ Yu Jiaao
The Affiliated Hospital of Jiangnan University/The First Hospital of Jilin University
Outcome results
None listed