This study will examine the tolerability of a gel formulation of the enzyme SN514 in patients with burns suitable for enzymatic debridement. In a rising dose fashion by sequential cohort, concentrations of 0.1%, 0.2%, 0.4% and 0.8% will be tested. Groups of 3 will undergo daily debridement for up to 7 days. Extent of debridement and adverse signs and symptoms will be recorded daily. Dose escalation will stop if a dose level is found to be intolerable. Dose escalation may accelerate if a tested dose is entirely ineffective. There is no placebo control as all burn wounds require debridement.
The design of the study is a sequential rising dose to the maximum tolerated dose, in which each subject will be exposed to only one concentration of the test article. Dose limiting toxicities are defined as "Severe" or CTCAE v5 Grade 3 or higher adverse events. This study in burn patients is designed to apply SN514-066b over 25 cm2 (0.14% TBSA for a 1.73 m2 adult) up to 500 cm2 (2.9%), at sequentially rising concentrations of 0.1%, 0.2%, 0.4% and 0.8% (\< 1.0 mg/cm2). The highest exposure would be 0.8% (8 g per 100 cc of gel) over 2.9% of 1.73 m2 = 800 mg or 11.4 mg/kg applied topically (70 kg patient).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Enzyme debrider
USAISR Burn Center
San Antonio, Texas, United States
Determine the maximum tolerated concentration of SN514 gel when applied topically to deep partial thickness burn wounds
Number of participants with treatment-related adverse events of Grade 3 or higher as assessed using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, where a higher grade on the scale of 1 to 5 is a worse outcome.
Time frame: Daily x 7days
Evaluate the time course and extent of debridement when applied daily for up to 7 days
Percent of eschar removed following each 24 hr debridement
Time frame: Daily x 7days
Evaluate effects of treatment on inflammation
Changes from baseline to end of treatment in blood levels of C-reactive protein (CRP) in mg/dL, serum tryptase in ng/mL, and total complement activity (CH50) level in hemolytic units.
Time frame: Daily x 7days
Observe the incidence of wound erythema
Record daily the appearance of new, spreading or darkening redness of the treated or adjacent tissue
Time frame: Daily x 7days
Incidence of wound purulence
Observe daily for the appearance of purulent material in the treatment area
Time frame: Daily for 7 days
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