| Eligibility |
Inclusion Criteria:
1. The combined TBSA of all burns is 10% or less.
2. Nonsmoker and must not have used any tobacco products within 2 months prior to
Screening.
3. Phase 1 only: Participants with TBSA < 10% who will undergo autologous skin grafting.
4. Phase 2a only: Participants with dermal burns who are within 5 days from the date of
wound and will be enrolled.
5. Phase 1 only: Those who have confirmed at least 1 donor wound site with an even
distribution of depth and extent of maximum 1% TBSA as judged by the Investigator.
6. Phase 2a only: Those who have confirmed at least 2 dermal burn sites with similar
depth and extent of 50 cm2 or more each as judged by the Investigator.
Exclusion Criteria:
1. Those who are allergic to or have experienced hypersensitivity to any components of
the IP or its excipients such as gelatin or hyaluronic acid ingredients.
2. Those with the following conditions for burns at the time of Screening in clinical
trials:
1. Those who have suffered chemical or electrical burns (for Phase 2a only).
2. Persons requiring tracheal intubation or tracheostomy due to severe inhalation
burns.
3. Those with burn wounds accompanied by trauma such as fractures or lacerations.
4. Persons with purulent infection of burn wounds.
5. Those who require treatment such as artificial mechanical ventilation,
extracorporeal membrane oxygen therapy, or dialysis due to other concomitant
diseases or conditions.
3. History of or active bleeding or coagulation diseases (eg, hemophilia, von
Willebrand's disease, thrombocytopenia, disseminated intravascular coagulation).
4. History of or active autoimmune diseases (eg, systemic lupus erythematosus, rheumatoid
arthritis, Sjögren's syndrome, Behcet's disease, and/or multiple sclerosis.
5. History of or active cardiovascular disease including clinically significant
arrhythmias, uncontrolled hypertension, coronary artery disease (CAD), and/or
prolonged QT interval (QTc > 450 msec for males and > 470 msec for females).
6. History of or active ischemic, hemorrhagic, or anatomical neurovascular disease
including, but not limited to, trans ischemic attack, cerebrovascular accident,
arterio-venous malformation, or brain aneurysm.
7. History of or active peripheral vascular disease such as deep vein thrombosis,
pulmonary embolism, chronic venous insufficiency, claudication, or lymphedema.
8. History of active pulmonary diseases including chronic obstructive pulmonary disease,
pulmonary fibrosis, moderate-to-severe sleep apnea, and moderate-to-severe asthma.
9. Active malignancy, other than local subcutaneous squamous cell and basal cell
carcinomas.
10. History of immunosuppressive, chemotherapeutic, or radiation treatment within the last
12 months prior to Screening.
11. History of type 1 diabetes or active type 2 diabetes.
12. History of severe endocrine disorders such as Cushing's disease, hypogonadism, and
growth hormone deficiency.
13. History or presence of severe active acute or chronic liver disease (eg, cirrhosis),
hepatic insufficiency defined as Child Pugh Class A or higher, nonalcoholic fatty
liver disease (NAFLD), nonalcoholic steatohepatitis (NASH), general hepatic disease
including serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 3
× the upper limit of normal.
14. Uncontrolled psychiatric disease including major depressive disorder, bipolar, anxiety
disorder, or eating disorders such as bulimia.
15. Those with serious diseases or condition that the Investigator believes may affect
wound healing, such as a malnourished, clinically significant vitamin and/or mineral
deficiencies.
16. Positive test for HIV, hepatitis B surface antigen (HBsAg), and hepatitis C virus
(HCV) antibody at the initial Screening Visit.
17. History of systemic active infectious diseases (eg, sepsis, tuberculosis) at the
initial Screening Visit.
18. Those who have a history of malignant tumor or lymphoproliferative disease or have
received an organ transplant within 5 years of initial Screening Visit.
19. Participants who have received systemic steroids, immunosuppressants, antiplatelet
agents or anticoagulants within 1 week before application of this clinical trial drug.
20. History of abnormal wound healing such as keloids or hypertrophic scars.
21. History of significant drug abuse within 12 months prior to Screening or positive
urine drug test at Screening.
22. Chronic kidney disease Stages 1 to 5.
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