Burn InjuryPhase 1/2NCT06628037
SN514-066b Enzyme in Deep Partial Thickness Burns
A Phase 1/2 study testing SN514-066b in people with Burn Injury, run by SERDA bv at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Burn Injury
- What is being tested?
- SN514-066b
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2025to May 2027
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- 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
Main Exclusion Criteria:
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Burn Injury
- Being tested
- SN514-066b
- Keywords
- Maximum tolerated dose, Debridement
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SN514-066bBiological
Enzyme debrider
| Study group | Role | What they receive |
|---|---|---|
| 1st cohort | Experimental | Testing 0.10% SN514-066b gel Receives: Biological: SN514-066b |
| 2nd cohort | Experimental | Testing 0.20% gel Receives: Biological: SN514-066b |
| 3rd cohort | Experimental | Testing 0.40% gel Receives: Biological: SN514-066b |
| 4th cohort | Experimental | Testing 0.80% gel Receives: Biological: SN514-066b |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Daily x 7days
Secondary outcomes (4)
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
Measured: 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.
Measured: 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
Measured: Daily x 7days
Incidence of wound purulence
Observe daily for the appearance of purulent material in the treatment area
Measured: Daily for 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start8 May 2025
- Primary completionDec 2026 (estimated)
- Study completionMay 2027 (estimated)
Why it stopped: Administrative Pause- NOT for Safety Reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SERDA bv
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Metis Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628037
- Sponsor's protocol ID
- SRDA-SN514-102
- Status last verified
- Aug 2026
- First submitted
- 2 Oct 2024
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Maximum Tolerated Dose Study of SN514-066b in Adult Patients With Deep Partial Thickness Dermal Burns
- ClinicalTrials.gov ID
- NCT06628037
- Acronym / sponsor ID
- SRDA-SN514-102
- Conditions
- Burn Injury
- Keywords
- Maximum tolerated dose, Debridement
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Administrative Pause- NOT for Safety Reasons
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- SERDA bvIndustry (pharma, biotech, devices)
- Collaborators
- The Metis Foundation
- Study start
- 8 May 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 4 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1st cohort | Experimental | Biological: SN514-066bTesting 0.10% SN514-066b gel |
| 2nd cohort | Experimental | Biological: SN514-066bTesting 0.20% gel |
| 3rd cohort | Experimental | Biological: SN514-066bTesting 0.40% gel |
| 4th cohort | Experimental | Biological: SN514-066bTesting 0.80% gel |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SN514-066bEnzyme debrider | Biological | 1st cohort, 2nd cohort, 3rd cohort, 4th cohort |
Primary outcome
Determine the maximum tolerated concentration of SN514 gel when applied topically to deep partial thickness burn wounds
Time frame: Daily x 7days
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.
4 secondary outcomes
Evaluate the time course and extent of debridement when applied daily for up to 7 days
Time frame: Daily x 7days
Evaluate effects of treatment on inflammation
Time frame: Daily x 7days
Observe the incidence of wound erythema
Time frame: Daily x 7days
Incidence of wound purulence
Time frame: Daily for 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SN514-066b in people with Burn Injury, run by SERDA bv at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.