Thermal BurnsPhase 2NCT06814717
A Safety, Tolerability and Pharmacokinetic Study of cP12 in Adults With Up To 10% Total Body Surface Area Burns
A Phase 2 study testing cP12 in people with Thermal Burns, run by Neomatrix Therapeutics, Inc. at 1 site in United States.
Trial summary
This is a Phase 2a, open-label, single-dose study to evaluate the safety, tolerability, and PK profile of cP12 in 6 male and female subjects with thermal burns of up to and including 10% TBSA. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thermal Burns
- What is being tested?
- cP12
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2025to 1 Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI between 18 kg/m2 (inclusive) and body weight >/=50kg
- TBSA thermal burns up to and including 10%. The selected burn must be superficial (epidermal), superficial partial-thickness, or deep partial-thickness
- Able to be infused with cP12 within 2 to 24 hours post burn
- Able to follow birth control requirements
Who cannot join
- Burns to the head, face and genitalia
- Smoke inhalation
- Active burn infection needing systemic antimicrobial treatment
- Full-thickness burn in the target burn
- Circumferential target burn
- Clinically significant laboratory abnormality or other clinical findings indicative of an exclusionary disease or medical history
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: A Phase 2a, Open-Label Study of the Safety, Tolerability, and Pharmacokinetics of a Single Dose of cP12 in Otherwise Healthy Adults With Up To and Including 10% Total Body Surface Area Thermal Burns
This is a Phase 2a, open-label, single-dose study to evaluate the safety, tolerability, and PK profile of cP12 in 6 male and female subjects with thermal burns of up to and including 10% TBSA. Enrolled subjects must have at least 1% superficial (epidermal), superficial partial-thickness, or deep partial-thickness burns.
Eligible subjects will receive a single administration of 0.01 mg/kg cP12. Vital signs, ECGs, and blood samples and urine samples will be obtained at screening and at several time points during the study for safety evaluation. Burn and pain assessments will be completed at specified times.
Read more
Subjects will remain at the clinical site for at least 6 hours post infusion for the purpose of safety monitoring and evaluation of other study assessments. Subsequent evaluations will be performed at the clinical site 3 (±1) days and 7 (±2) days after dosing.
Subjects will return to the clinical site 14 (±2) days after dosing for an End-of-Study visit.
Read the detailed description
This is a Phase 2a, open-label, single-dose study to evaluate the safety, tolerability, and PK profile of cP12 in 6 male and female subjects with thermal burns of up to and including 10% TBSA. Enrolled subjects must have at least 1% superficial (epidermal), superficial partial-thickness, or deep partial-thickness burns. With the exception of the burns, subjects should be healthy and will be assessed to rule out smoke inhalation and other injuries. Vital signs prior to dosing must be stable and an electrocardiogram (ECG) must not show clinically significant abnormalities.
The target burn used in this study will be selected based on a burn classification description conducted prior to dosing with cP12. The selected burn must be superficial (epidermal), superficial partial-thickness, or deep partial-thickness and must not be a circumferential burn.
In the absence of burn-specific, validated assessment tools, NeoMatrix has developed scales to characterize the burn and surrounding tissues for this trial. Burn assessments will include erythema, capillary refill, blisters, and edema/swelling. In this trial, the target burn and all other burns of each subject will be assessed.
Eligible subjects will receive a single administration of 0.01 mg/kg cP12. Study drug will be administered over approximately 30 minutes by intravenous (IV) infusion with the subject in a supine position, and the infusion is to be initiated and completed within 2 to 24 hours after the burn has occurred. The subject is to remain in the supine position for 60 minutes from the start of study drug infusion (ie, during the 30-minute infusion and for 30 minutes after study drug infusion).
Vital signs, ECGs, and blood samples and urine samples will be obtained at screening and at several time points during the study for safety evaluation. Burn and pain assessments will be completed at specified times.
Subjects will remain at the clinical site for at least 6 hours post infusion for the purpose of safety monitoring and evaluation of other study assessments. Subsequent evaluations will be performed at the clinical site 3 (±1) days and 7 (±2) days after dosing.
Subjects will return to the clinical site 14 (±2) days after dosing for an End-of-Study visit.
- Conditions
- Thermal Burns
- Being tested
- cP12
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cP12Drug
cP12 is a novel fibronectin derived, 14-mer peptide
| Study group | Role | What they receive |
|---|---|---|
| Open-label | Experimental | Six adult male or female subjects will receive a single administration of 0.01mg/kg of cP12. Receives: Drug: cP12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events from dosing through follow-up
Clinical safety labs will be collected
Measured: Day 1, Day 3 and Day 14
Incidence and severity of adverse events from dosing through follow-up
Electrocardiograms will be performed
Measured: Day 1 (Baseline and 1hour, 6 hours postdose), Day 3 and Day 14
Incidence and severity of adverse events from dosing through follow-up
Vital signs will be collected
Measured: Baseline, Day 1 (2,5,15,30,60,90,120,240,360 minutes postdose), Day 3, Day 7 and Day 14
Secondary outcomes (4)
Investigate pharmacokinetic profile
Blood samples will be analyzed for maximum plasma concentration (Cmax)
Measured: Predose, 2,5,15,30,60,120 and 240 minutes post dose
Investigate pharmacokinetic profile
Blood samples will be analyzed for area under the plasma concentration (AUC) versus time curve
Measured: Predose, 2,5,15,30,60,120 and 240 minutes post dose
Investigate pharmacokinetic profile
Blood samples will be analyzed for half-life (t1/2)
Measured: Predose, 2,5,15,30,60,120 and 240 minutes post dose
Investigate pharmacokinetic profile
Blood samples will be analyzed for time to reach maximum plasma concentration (Tmax)
Measured: Predose, 2,5,15,30,60,120 and 240 minutes post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start12 May 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thermal BurnsStudies 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 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Safety study
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neomatrix Therapeutics, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Jeffrey Shupp, MD, Principal investigator, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814717
- Sponsor's protocol ID
- NMT-cP12-201
- Status last verified
- Feb 2026
- First submitted
- 17 Jan 2025
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Open-Label Study of the Safety, Tolerability, and Pharmacokinetics of a Single Dose of cP12 in Otherwise Healthy Adults With Up To and Including 10% Total Body Surface Area Thermal Burns
- ClinicalTrials.gov ID
- NCT06814717
- Acronym / sponsor ID
- NMT-cP12-201
- Conditions
- Thermal Burns
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Neomatrix Therapeutics, Inc.University, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 12 May 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 7 Feb 2025 (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 is a Phase 2a, open-label, single-dose study to evaluate the safety, tolerability, and PK profile of cP12 in 6 male and female subjects with thermal burns of up to and including 10% TBSA. Enrolled subjects must have at least 1% superficial (epidermal), superficial partial-thickness, or deep partial-thickness burns.
Eligible subjects will receive a single administration of 0.01 mg/kg cP12. Vital signs, ECGs, and blood samples and urine samples will be obtained at screening and at several time points during the study for safety evaluation. Burn and pain assessments will be completed at specified times.
Subjects will remain at the clinical site for at least 6 hours post infusion for the purpose of safety monitoring and evaluation of other study assessments. Subsequent evaluations will be performed at the clinical site 3 (±1) days and 7 (±2) days after dosing.
Subjects will return to the clinical site 14 (±2) days after dosing for an End-of-Study visit.
Detailed description
This is a Phase 2a, open-label, single-dose study to evaluate the safety, tolerability, and PK profile of cP12 in 6 male and female subjects with thermal burns of up to and including 10% TBSA. Enrolled subjects must have at least 1% superficial (epidermal), superficial partial-thickness, or deep partial-thickness burns. With the exception of the burns, subjects should be healthy and will be assessed to rule out smoke inhalation and other injuries. Vital signs prior to dosing must be stable and an electrocardiogram (ECG) must not show clinically significant abnormalities.
The target burn used in this study will be selected based on a burn classification description conducted prior to dosing with cP12. The selected burn must be superficial (epidermal), superficial partial-thickness, or deep partial-thickness and must not be a circumferential burn.
In the absence of burn-specific, validated assessment tools, NeoMatrix has developed scales to characterize the burn and surrounding tissues for this trial. Burn assessments will include erythema, capillary refill, blisters, and edema/swelling. In this trial, the target burn and all other burns of each subject will be assessed.
Eligible subjects will receive a single administration of 0.01 mg/kg cP12. Study drug will be administered over approximately 30 minutes by intravenous (IV) infusion with the subject in a supine position, and the infusion is to be initiated and completed within 2 to 24 hours after the burn has occurred. The subject is to remain in the supine position for 60 minutes from the start of study drug infusion (ie, during the 30-minute infusion and for 30 minutes after study drug infusion).
Vital signs, ECGs, and blood samples and urine samples will be obtained at screening and at several time points during the study for safety evaluation. Burn and pain assessments will be completed at specified times.
Subjects will remain at the clinical site for at least 6 hours post infusion for the purpose of safety monitoring and evaluation of other study assessments. Subsequent evaluations will be performed at the clinical site 3 (±1) days and 7 (±2) days after dosing.
Subjects will return to the clinical site 14 (±2) days after dosing for an End-of-Study visit.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Safety study
| Arm | Type | Receives |
|---|---|---|
| Open-label | Experimental | Drug: cP12Six adult male or female subjects will receive a single administration of 0.01mg/kg of cP12. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI between 18 kg/m2 (inclusive) and body weight >/=50kg
- TBSA thermal burns up to and including 10%. The selected burn must be superficial (epidermal), superficial partial-thickness, or deep partial-thickness
- Able to be infused with cP12 within 2 to 24 hours post burn
- Able to follow birth control requirements
Key exclusion criteria (6 listed)
- Burns to the head, face and genitalia
- Smoke inhalation
- Active burn infection needing systemic antimicrobial treatment
- Full-thickness burn in the target burn
- Circumferential target burn
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 |
|---|---|---|
| cP12cP12 is a novel fibronectin derived, 14-mer peptide | Drug | Open-label |
Primary outcome
Incidence and severity of adverse events from dosing through follow-up
Time frame: Day 1, Day 3 and Day 14
Clinical safety labs will be collected
Incidence and severity of adverse events from dosing through follow-up
Time frame: Day 1 (Baseline and 1hour, 6 hours postdose), Day 3 and Day 14
Electrocardiograms will be performed
Incidence and severity of adverse events from dosing through follow-up
Time frame: Baseline, Day 1 (2,5,15,30,60,90,120,240,360 minutes postdose), Day 3, Day 7 and Day 14
Vital signs will be collected
4 secondary outcomes
Investigate pharmacokinetic profile
Time frame: Predose, 2,5,15,30,60,120 and 240 minutes post dose
Investigate pharmacokinetic profile
Time frame: Predose, 2,5,15,30,60,120 and 240 minutes post dose
Investigate pharmacokinetic profile
Time frame: Predose, 2,5,15,30,60,120 and 240 minutes post dose
Investigate pharmacokinetic profile
Time frame: Predose, 2,5,15,30,60,120 and 240 minutes post dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Jeffrey Shupp, MD principal investigator
Medstar Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cP12 in people with Thermal Burns, run by Neomatrix Therapeutics, Inc. 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?
The sponsor lists 4 inclusion and 6 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 18 Feb 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 phase mean?
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cara Delatore (202-877-6402, cara.m.delatore@medstar.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events from dosing through follow-up (time frame: Day 1, Day 3 and Day 14). The study lists 3 primary outcomes in all. 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 18 Feb 2026.