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ENROLLING BY INVITATION
NCT06628037
PHASE1/PHASE2

SN514-066b Enzyme in Deep Partial Thickness Burns

Sponsor: SERDA bv

View on ClinicalTrials.gov

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

BIOLOGICAL

SN514-066b

Enzyme debrider

Locations (1)

USAISR Burn Center

San Antonio, Texas, United States