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SN514-066b Enzyme in Deep Partial Thickness Burns
Sponsor: SERDA bv
Summary
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.
Official title: A Phase 1 Maximum Tolerated Dose Study of SN514-066b in Adult Patients With Deep Partial Thickness Dermal Burns
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
27
Start Date
2025-05-08
Completion Date
2026-05
Last Updated
2025-05-13
Healthy Volunteers
No
Conditions
Interventions
SN514-066b
Enzyme debrider
Locations (1)
USAISR Burn Center
San Antonio, Texas, United States