SN514-066b Enzyme in Deep Partial Thickness Burns

NCT06628037 | Enrolling By Invitation Phase 1 DMC FDA Drug

• 1 other identifier: SRDA-SN514-102
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Burn Injury

Keywords

Maximum tolerated dose; Debridement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Evaluate the time course and extent of debridement when applied daily for up to 7 days

  Daily x 7days

• Evaluate effects of treatment on inflammation

  Daily x 7days

• Observe the incidence of wound erythema

  Daily x 7days

• Incidence of wound purulence

  Daily for 7 days

Study Arms (4)

1st cohort

EXPERIMENTAL

Testing 0.10% SN514-066b gel

Biological: SN514-066b

2nd cohort

EXPERIMENTAL

Testing 0.20% gel

Biological: SN514-066b

3rd cohort

EXPERIMENTAL

Testing 0.40% gel

Biological: SN514-066b

4th cohort

EXPERIMENTAL

Testing 0.80% gel

Biological: SN514-066b

Interventions

SN514-066b BIOLOGICAL

Enzyme debrider

1st cohort; 2nd cohort; 3rd cohort; 4th cohort

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Thermal burns caused by fire/flame, scalds or contact
• 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)
• Target burns for treatment is deep partial thickness (DPT) in depth

You may not qualify if:

• Subject has another life threatening traumatic injury
• 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
• Poorly controlled diabetes mellitus (HbA1c \>12%)
• BMI greater than 40 kg/m2
• 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)
• Pre-existing diseases which interfere with circulation (severe peripheral vascular disease, severe circulatory edema and/or lymphedema, regional lymph nodes dissection, significant varicose veins)
• 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)

Sponsors & Collaborators

• SERDA bv: lead
• The Metis Foundation: collaborator

Study Sites (1)

USAISR Burn Center

San Antonio, Texas, 78234, United States

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 4, 2024
• Study Start: May 8, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Locations

US (1)