SN514-066b for Burns

Overseen By Victoria Diaz, RN

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: SERDA bv

Disqualifiers: Diabetes, Cardio-pulmonary disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 1 week

27 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for patients with deep partial thickness burns caused by fire, scalds, or contact. The treatable burn area must be between 25 to 500 cm2 and not include the face, hands, genitalia, or areas at high risk of compartment syndrome.

Inclusion Criteria

Main

I have burn areas between 25 to 500 cm2 not including face, hands, genitalia, or high-risk areas.

I have burns from fire, hot liquids, or direct contact with heat.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive daily debridement with SN514-066b gel at varying concentrations for up to 7 days

1 week

Daily visits for 7 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• SN514-066b

Trial Overview The study tests a gel called SN514-066b for enzymatic debridement of burns. Patients will receive increasing concentrations (0.1%, 0.2%, 0.4%, and 0.8%) in groups of three with daily treatment up to seven days to assess tolerability and effectiveness.

Participant Groups

Group I: 4th cohort Experimental Treatment 1 Intervention

Testing 0.80% gel

Group II: 3rd cohort Experimental Treatment 1 Intervention

Testing 0.40% gel

Group III: 2nd cohort Experimental Treatment 1 Intervention

Testing 0.20% gel

Group IV: 1st cohort Experimental Treatment 1 Intervention

Testing 0.10% SN514-066b gel

Who Is Running the Clinical Trial?

SERDA bv

Lead Sponsor

Trials

1

Recruited

30+

The Metis Foundation

Collaborator

Trials

13

Recruited

750+