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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new gel, SN514-066b, to evaluate its effectiveness and safety for treating burns requiring enzymatic debridement (removal of dead tissue). The trial will assess different gel strengths to determine the optimal dose, with each group trying a different dose up to 0.8%. Individuals with deep partial thickness burns from flames, scalds, or contact burns, excluding those on the face, hands, or sensitive areas, and without severe health issues or infections, may qualify. The goal is to determine how much dead tissue the gel can safely remove each day for up to a week. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that SN514-066b is likely to be safe for humans?

Research has shown that SN514-066b has potential based on lab and animal studies. The enzyme in the gel breaks down proteins like fibrin, elastin, and collagen, which are crucial for cleaning burn wounds. Tests on pigs with burn wounds demonstrated that SN514-066b effectively removed dead tissue.

In another study using human burn tissue, the gel significantly reduced tissue weight, indicating effective removal of dead tissue. However, these studies primarily focus on the gel's efficacy, not its safety in humans.

This trial is in the early stages, with the main goal of assessing the treatment's safety and tolerability in humans. The gel has not been extensively tested in people, so researchers are still gathering safety information. If the treatment progresses to later testing stages, it typically indicates it has been deemed safe enough to continue. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for burns?

Researchers are excited about SN514-066b gel for burns because it offers a new approach to healing damaged skin. Unlike the standard treatments like silver sulfadiazine creams and aloe vera gels, which focus on preventing infection and soothing the skin, SN514-066b is designed to potentially enhance the skin's natural healing process. The gel comes in varying concentrations (0.10% to 0.80%), allowing researchers to fine-tune its effectiveness and safety. This innovative approach could lead to faster recovery times and improved outcomes for burn victims, making it a promising advancement in burn care.

What evidence suggests that SN514-066b might be an effective treatment for burns?

Studies have shown that SN514-066b gel holds promise for treating burns by aiding in the removal of dead tissue. In lab tests, SN514 effectively breaks down proteins in burned skin. Research using Yorkshire pigs demonstrated that the gel efficiently cleans burn wounds. Specifically, treatment with SN514 gel resulted in more than an 80% reduction in the weight of treated human burn tissue compared to untreated samples. These findings suggest SN514-066b could be a powerful tool in helping burns heal by clearing away dead tissue. This trial will test different concentrations of SN514-066b gel, ranging from 0.10% to 0.80%, to evaluate its effectiveness and safety in treating burns. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. liebertpub.com liebertpub.com/doi/10.1089/wound.2024.0215

Effects of a New Enzymatic Debrider (SN514-066b) on ... Results: SN514 showed excellent digestion of fibrin, elastin, and collagen in vitro. Burn wound studies in Yorkshire pigs showed efficient ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39853227/

Effects of a New Enzymatic Debrider (SN514-066b) on ... Results: SN514 showed excellent digestion of fibrin, elastin, and collagen in vitro. Burn wound studies in Yorkshire pigs showed efficient ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06628037

SN514-066b Enzyme in Deep Partial Thickness Burns 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 ...

4. researchgate.net researchgate.net/publication/342649648_Enzymatic_Debridement_of_Porcine_Burn_Wounds_via_a_Novel_Protease_SN514

(PDF) Enzymatic Debridement of Porcine Burn Wounds via ... Treatment of human burned tissue with SN514 gel resulted in greater than 80% weight reduction compared to untreated samples.

5. synapse.patsnap.com synapse.patsnap.com/drug/c6a24e063451452a94c6b2238afd1959

SN-514 - Drug Targets, Indications, Patents Treatment of human burned tissue with SN514 gel resulted in greater than 80% weight reduction compared with untreated samples.

6. withpower.com withpower.com/trial/sn514-066b-for-burns-2a7f3

SN514-066b for Burns · Info for Participants This study will examine the tolerability of a gel formulation of the enzyme SN514 in patients with burns suitable for enzymatic debridement.

7. liebertpub.com liebertpub.com/doi/pdf/10.1089/wound.2024.0215

Effects of a New Enzymatic Debrider (SN514-066b) on ... We report here key findings from studies of in vitro enzyme activity and ani- mal burn wound debridement, followed by the results of a first in human 21-day ...