Wound in medium-thick donor site
Conditions
Interventions
Low-dose group:Low dose test drug
Medium dose group:Medium dose test drug
High-dose group:High-dose test drug
Repeated administration group:Repeated administration
Control group:None
Sponsors
Nanjing Gritpharma Co., Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. No gender limit, subjects aged 18-60 years (including the boundary value); 2. Subjects who intend to undergo autologous skin harvesting; 3. The wound surface of the target donor site is between 60 and 90cm^2, and the outer thigh is selected as the donor site; 4. The skin donor area is the first skin donation, and the skin donor area is a medium-thick skin slice with a thickness of about 0.4-0.6 mm; 5. Subjects (males and females with reproductive potential) and their sexual partners are willing to have no reproductive plan from 4 weeks before screening to 6 months after the last dose of the test drug, and voluntarily take effective contraceptive measures and do not donate sperm, egg donation program; 6. Subjects can understand the procedures and methods of this clinical trial, agree to participate in the research, and voluntarily sign the informed consent form, and the investigator judges that they can comply with the requirements of the protocol.
Exclusion criteria
Exclusion criteria: 1. Known allergy to GP51801, any component of the preparation, or other similar drugs; 2. Severe burns with special causes (such as electric injury, chemical burn, radiation injury, etc.); Skin burn area >30% total body surface area (TBSA); 3. Critically ill patients with multiple or combined injuries such as inhalation injury and trauma; 4. Patients with serious contamination or infection on the proposed donor skin wound; 5. Cicatricial constitution; 6. Patients with serious organ dysfunction of heart, brain, liver, kidney, or related skin diseases that may cause wound surface to fail to heal normally; Malignant tumors, severe malnutrition and other chronic diseases that may affect wound healing; The patient's condition may affect the evaluation of the study or may require a combination of medical treatments that may affect the evaluation of efficacy; 7. Patients with diabetes mellitus or unstable blood glucose control, such as fasting blood glucose >=8.0mmol/L or postprandial blood glucose >=12.0mmol/L or HBA1c greater than the upper limit of normal, were judged by researchers as abnormal and clinically significant; 8. Organ transplant recipients (except those covered by allogeneic or xenograft skin on burn wounds and autologous skin transplantation); 9. Previous history of scleroderma, rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus; 10. ANA positive patients with ANA titer > 1:160 during the screening period; 11. Patients with immune dysfunction, HIV infection, or receiving radiation, hormonal (systemic), chemotherapy, growth factors, and immunosuppressive drugs within 1 month before enrollment; 12. Patients who had received angiogenesis related growth factor or stem cell therapy within 1 year before enrollment; 13. Those who received live vaccine (excluding COVID-19 vaccine) within 4 weeks prior to enrolling, or received COVID-19 vaccine within 14 days prior to enrolling, or planned to receive vaccine within 4 weeks after administration; 14. Patients who are pregnant or lactating, or who test positive for blood pregnancy; 15. Participated in clinical trials and used experimental drugs or devices within 12 weeks prior to enrollment; 16. Patients with mental illness, lack of self-awareness and inability to express themselves accurately; 17. Other conditions deemed unsuitable for participation in the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events/serious adverse events;Tolerability and safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Wound healing time and healing rate; | — |
Countries
China
Contacts
Public ContactLuo Qi
Nanjing Gritpharma Co., Ltd.
Outcome results
None listed