Various types of chronic non-healing wounds (including diabetic foot ulcers, pressure ulcers) and fresh wounds (including traumatic injuries, donor site wounds, surgical wounds, etc.)
Conditions
Interventions
Experimental group:GD-N1801
Control group:Placebo
Sponsors
West China Hospital,Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: (1) Male or female, aged 18 to 45 years at the screening visit; (2) Male participants must weigh no less than 60 kg, and female participants must weigh no less than 50 kg. Body mass index (BMI) between 19.5 and 26 kg/m² (inclusive of boundary values); (3) No scars, tattoos, birthmarks, or obvious pigmentation, and no skin damage or abnormalities at the target application site that could affect evaluation; (4) Voluntary participation in the study with a signed informed consent form, including the date; (5) For female participants: a) No reproductive potential, including at least 6 weeks of surgical sterilization (with documented tubal ligation, hysterectomy, or bilateral oophorectomy), or menopause =12 months prior to screening visit; b) For those with reproductive potential, must be non-pregnant, non-lactating, and must use non-pharmacological contraception during the screening/baseline phase, study period, and for 3 months following the end of treatment, with a negative human chorionic gonadotropin (HCG) test at screening visit and Day -1. Participants may not donate ova during this period; (6) For male participants with a female partner of reproductive potential, non-pharmacological contraception must be used during the screening/baseline phase, study period, and for 3 months following the end of treatment. Male participants may not donate sperm during this period; (7) Willingness to comply with the study protocol requirements, including visits, study treatments, laboratory tests, and other related procedures.
Exclusion criteria
Exclusion criteria: (1) Individuals allergic to the main components or excipients of GD-N1801 topical solution, or those with a history of allergic reactions; (2) Blood donation or significant blood loss (>= 200 mL), receiving a blood transfusion or using blood products within 3 months prior to screening; (3) Participation in other clinical trials for new drugs or medical devices within 3 months prior to screening, and having used the investigational drug or medical device; (4) Use of any known potent liver enzyme inducers or inhibitors within 28 days prior to screening; (5) Smokers or those who have smoked more than 5 cigarettes per day in the 3 months prior to screening, or those who are unable to stop using any tobacco products during the trial period; (6) Alcoholics or those who have consumed more than 14 units of alcohol per week in the 3 months prior to screening (1 unit = 360 mL beer, 45 mL of 40% alcohol spirits, or 150 mL of wine), or those with a positive baseline alcohol breath test, or those unable to stop using alcohol-containing products during the trial period; (7) Consumption of any food or beverage containing caffeine, xanthine, or grapefruit (such as tea, chocolate, coffee, cola, etc.) within 48 hours prior to drug administration, or those who disagree to stop consuming these foods or beverages during the study; (8) Drug abusers or those with a positive baseline drug abuse screening; (9) Positive screening for hepatitis B surface antigen, hepatitis C virus antibodies, human immunodeficiency virus antibodies, or syphilis antibodies; (10) Planned participation in vigorous exercise, including contact sports or collision sports during the trial; (11) Individuals with special dietary requirements who cannot adhere to a unified diet during the study; (12) Individuals who cannot tolerate venipuncture or have difficulty with venous blood draws, or those with a history of fainting during blood draws; (13) Abnormal vital signs or abnormal findings in physical examination, electrocardiogram, laboratory tests, etc., judged by the investigator to be clinically significant; (14) History or current clinical serious diseases affecting the cardiovascular, endocrine, nervous, digestive, respiratory, urogenital, hematologic, immunologic, psychiatric, metabolic systems, or malignancies, or any other diseases that may interfere with the trial results; (15) History or current skin diseases judged by the investigator to interfere with trial result evaluation (including but not limited to psoriasis, eczema, acne, atopic dermatitis, dysplastic nevi, etc.); (16) Use of any medication or supplement (including herbal medicine) within 14 days prior to screening or within 5 half-lives of the drug (whichever is longer), or use of any topical skin products in the target application area; (17) Any other condition judged by the investigator that may prevent the participant from completing the study or make them unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters; | — |
Countries
China
Contacts
Public ContactFeng Ping
West China Hospital,Sichuan University
Outcome results
None listed