SN514-066b Enzyme in Deep Partial Thickness Burns

Part of paid clinical trials in San Antonio, Texas.

Sponsor
SERDA bv
Study ID
NCT06628037
Phase
PHASE1/PHASE2
Status
Enrolling By Invitation

Conditions

  • Burn Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • SN514-066b — BIOLOGICAL
    Enzyme debrider

Study Details

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.

Key Dates

Start date
May 8, 2025
Status verified
May 2025
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
27 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 1st cohort
    Testing 0.10% SN514-066b gel
  • Experimental: 2nd cohort
    Testing 0.20% gel
  • Experimental: 3rd cohort
    Testing 0.40% gel
  • Experimental: 4th cohort
    Testing 0.80% gel

Primary Outcome Measure

Determine the maximum tolerated concentration of SN514 gel when applied topically to deep partial thickness burn wounds [ Time Frame: Daily x 7days ]

Locations (1)

FacilityCityStateZIPSite coordinators
USAISR Burn CenterSan AntonioTexas78234-

Find similar trials in San Antonio, TX

By research site
USAISR Burn Center· San Antonio, TX

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