SN514-066b Enzyme in Deep Partial Thickness Burns

A Phase 1 Maximum Tolerated Dose Study of SN514-066b in Adult Patients With Deep Partial Thickness Dermal 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 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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Burn Injury
• Intervention / Treatment: Biological: SN514-066b

Detailed Description

The design of the study is a sequential rising dose to the maximum tolerated dose, in which each subject will be exposed to only one concentration of the test article. Dose limiting toxicities are defined as "Severe" or CTCAE v5 Grade 3 or higher adverse events. This study in burn patients is designed to apply SN514-066b over 25 cm2 (0.14% TBSA for a 1.73 m2 adult) up to 500 cm2 (2.9%), at sequentially rising concentrations of 0.1%, 0.2%, 0.4% and 0.8% (< 1.0 mg/cm2). The highest exposure would be 0.8% (8 g per 100 cc of gel) over 2.9% of 1.73 m2 = 800 mg or 11.4 mg/kg applied topically (70 kg patient).

• Study Type: Interventional
• Enrollment (Estimated): 27
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78234
      • USAISR Burn Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Main Inclusion Criteria:

1. Thermal burns caused by fire/flame, scalds or contact
2. Total burns area available for treatment is 25 to 500 cm2 (a larger area may be burned, but the treatment area must be limited to the stated size, and the treatment area must be exclusive of face, hands, genitalia and sites deemed to be at high risk for developing compartment syndrome)
3. Target burns for treatment is deep partial thickness (DPT) in depth

Main Exclusion Criteria:

1. Subject has another life threatening traumatic injury

2. Patient's proposed study wound site has any of the following conditions:

   • Electrical or chemical etiology
   • Pre-enrollment escharotomy
   • Area is devoid of circulation
   • Located on the face, perineum or genitalia
   • Clinical evidence of wound infection
3. Poorly controlled diabetes mellitus (HbA1c >12%)
4. BMI greater than 40 kg/m2
5. Cardio-pulmonary disease (MI within 6 months prior to injury, severe or unstable ischemic heart disease, severe or unstable heart failure, severe pulmonary hypertension, severe COPD or pre-existing oxygen-dependent pulmonary diseases, severe broncho-pneumonia within 1 month prior to injury, steroid dependent asthma, or uncontrolled asthma)
6. Pre-existing diseases which interfere with circulation (severe peripheral vascular disease, severe circulatory edema and/or lymphedema, regional lymph nodes dissection, significant varicose veins)
7. Any conditions that would preclude safe treatment or adding further risk to the basic acute burn trauma (such as severe immuno-compromising diseases, life threatening trauma, severe pre-existing coagulation disorder, severe cardiovascular disorder, significant pulmonary disorder, significant liver disorder including post alcoholic abuse impaired function or neoplastic disease, blast injury)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1st cohort; Testing 0.10% SN514-066b gel	Biological: SN514-066b; Enzyme debrider
Experimental: 2nd cohort; Testing 0.20% gel	Biological: SN514-066b; Enzyme debrider
Experimental: 3rd cohort; Testing 0.40% gel	Biological: SN514-066b; Enzyme debrider
Experimental: 4th cohort; Testing 0.80% gel	Biological: SN514-066b; Enzyme debrider

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the maximum tolerated concentration of SN514 gel when applied topically to deep partial thickness burn wounds	Number of participants with treatment-related adverse events of Grade 3 or higher as assessed using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, where a higher grade on the scale of 1 to 5 is a worse outcome.	Daily x 7days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the time course and extent of debridement when applied daily for up to 7 days	Percent of eschar removed following each 24 hr debridement	Daily x 7days
Evaluate effects of treatment on inflammation	Changes from baseline to end of treatment in blood levels of C-reactive protein (CRP) in mg/dL, serum tryptase in ng/mL, and total complement activity (CH50) level in hemolytic units.	Daily x 7days
Observe the incidence of wound erythema	Record daily the appearance of new, spreading or darkening redness of the treated or adjacent tissue	Daily x 7days
Incidence of wound purulence	Observe daily for the appearance of purulent material in the treatment area	Daily for 7 days

Collaborators and Investigators

• Sponsor: SERDA bv
• Collaborators: The Metis Foundation

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: October 2, 2024
• First Submitted That Met QC Criteria: October 3, 2024
• First Posted (Actual): October 4, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2025
• Last Update Submitted That Met QC Criteria: May 7, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Maximum tolerated dose; Debridement
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: SRDA-SN514-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: This is a single center trial. If a subsequent burn study is conducted, then certain data may be shared with future investigators. All data are submitted to the IND.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No