drugset / Trial / NCT06628037
SN514-066b Enzyme in Deep Partial Thickness Burns
Non-randomizedSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2025-05-08
- Primary completion
- 2026-05
- Completion
- 2026-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SN514-066b | Protein / enzyme biologic | 0.1 % | Topical |
| Subject | SN514-066b | Protein / enzyme biologic | 0.2 % | Topical |
| Subject | SN514-066b | Protein / enzyme biologic | 0.4 % | Topical |
| Subject | SN514-066b | Protein / enzyme biologic | 0.8 % | Topical |
Indications
No indication recorded.