cP12 for Thermal Burns

Recruiting at 1 trial location

Overseen By Cara Delatore

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Neomatrix Therapeutics, Inc.

Disqualifiers: Burns to head, face, genitalia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 1 day

6 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effects of a new treatment called cP12 for people with thermal burns. It targets individuals with burns covering up to 5% of their body, with at least 1% being deep partial-thickness. Participants will receive a single dose of cP12 and undergo close monitoring for any reactions or improvements. Ideal candidates are those who have recently experienced a burn and meet the specific burn criteria. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in burn care.

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 cP12 is likely to be safe for humans?

Research has not yet provided specific safety information for cP12 in humans. However, this trial is in an early stage, so researchers are primarily focused on assessing the safety of cP12 and its tolerability. During this phase, they closely monitor participants for any side effects.

As the study involves administering a single dose to a small group, any side effects should become apparent quickly. Researchers will regularly check participants' vital signs and other health indicators to ensure safety. This careful approach helps identify any issues early and maintains participant safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for thermal burns, such as topical antibiotics and silver-based dressings, cP12 offers a unique approach. Researchers are excited about cP12 because it works differently by potentially enhancing the body's natural healing processes at a cellular level. This new treatment also has a novel delivery system, as it is administered at a precise dosage based on body weight, which could lead to more personalized and effective care. By targeting the underlying mechanisms of burn healing, cP12 might offer quicker recovery times and improved outcomes for patients.

What evidence suggests that cP12 might be an effective treatment for thermal burns?

Research has shown that cP12 could help treat burns caused by heat. Animal studies demonstrated that cP12 can slow burn progression and promote faster healing. This suggests the drug might reduce burn severity and accelerate recovery. These findings indicate that cP12 could benefit people with heat-induced burns. Although human data remains limited, these early results are promising. Participants in this trial will receive a single administration of cP12 to further evaluate its potential benefits in humans. ^{2 5 6 7 8}

Who Is on the Research Team?

Jeffrey Shupp, MD

Principal Investigator

Medstar Health Research Institute

Are You a Good Fit for This Trial?

This trial is for adults with small area burns (up to 5% of their body). They should have a BMI within normal range and weigh at least 50kg. Participants must have at least one deep partial-thickness burn and be able to receive the study drug between 2-12 hours after being burned. They also need to follow birth control guidelines.

Inclusion Criteria

Able to follow birth control requirements

My BMI is at least 18 and I weigh 50kg or more.

I have burns covering up to 5% of my body, including a deep burn.

Exclusion Criteria

Circumferential target burn

Smoke inhalation

I have burns on my head, face, or genital area.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive a single administration of 0.01 mg/kg cP12 via IV infusion

1 day

1 visit (in-person)

Immediate Post-Treatment Monitoring

Subjects remain at the clinical site for at least 6 hours post infusion for safety monitoring

6 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

3 visits (in-person) on Day 3, Day 7, and Day 14

What Are the Treatments Tested in This Trial?

Interventions

• cP12

Trial Overview The study tests cP12, a new treatment for burn pain and healing. It's an open-label trial where all participants know they're getting the drug in a single dose of 0.01 mg/kg. Their health will be closely watched through vital signs, ECGs, blood and urine tests, as well as assessments of their burns and pain levels.

How Is the Trial Designed?

Group I: Open-label Experimental Treatment 1 Intervention

Six adult male or female subjects will receive a single administration of 0.01mg/kg of cP12.

Who Is Running the Clinical Trial?

Neomatrix Therapeutics, Inc.

Lead Sponsor

Trials

2

Recruited

40+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

The web-based adverse event tracking system (eAETS) has effectively supported 175 clinical protocols over four years, capturing 2,440 adverse event reports, including minor symptoms that could indicate serious issues.

Out of the reported AEs, 1,053 did not align with the initial risk profiles, leading to corrective recommendations in 13% of the protocols, highlighting the system's role in enhancing subject safety by identifying unanticipated patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of minor adverse event tracking on subject safety: a web-based system. Shenvi, NV., Gebhart, SS.[2009]

The STEP database is a new resource that compiles safety and toxicity data for excipients used in pediatric formulations, addressing the need for accessible and organized information that is often scattered across various sources.

Currently containing data from over 2000 references on 10 excipients, the database allows users to search for and by excipients, making it a unique tool for researchers and developers in ensuring the safety of pediatric medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The STEP (Safety and Toxicity of Excipients for Paediatrics) database: part 2 - the pilot version. Salunke, S., Brandys, B., Giacoia, G., et al.[2022]

A new assignment for specialist oncology nurses on adverse drug reaction (ADR) reporting resulted in 97% of the 33 reported ADRs being well documented, demonstrating the nurses' capability in pharmacovigilance.

The majority of nurses found the assignment useful and reported that it increased their awareness of medication safety, with 84% stating it changed how they managed ADRs in their practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The adverse drug reaction reporting assignment for specialist oncology nurses: a preliminary evaluation of quality, relevance and educational value in a prospective cohort study. Schutte, T., van Eekeren, R., Richir, M., et al.[2019]

Juvenile toxicology studies in animals are essential for understanding potential adverse effects of medications on children's growth and development, but additional monitoring approaches are needed for safety in the pediatric population.

A proposed post-marketing risk management program for children with Juvenile Inflammatory Arthritis (JIA) taking NSAIDs aims to identify adverse events, including those with longer latency, highlighting the need for comprehensive safety monitoring beyond standard clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Essentials for starting a pediatric clinical study (4): Clinical pediatric safety planning based on preclinical toxicity studies and pediatric pharmacovigilance guidance. Sheth, N.[2019]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK541209/

Cooling for Thermal Burns: Clinical Effectiveness and ... - NCBI Current guidelines generally agree that cooling with running water is effective in mitigating cell damage and reducing wound size.

2. withpower.com withpower.com/trial/phase-2-thermal-burns-4-2025-4fbdc

cP12 for Thermal Burns · Recruiting Participants for Phase ... 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 ...

3. apps.dtic.mil apps.dtic.mil/sti/trecms/pdf/AD1205232.pdf

A Phase 1 Randomized, Placebo-Controlled, Single ... - DTIC Collectively, the cP12 animal efficacy data indicate that this drug has a positive effect on both burn progression and burn healing.

4. ctv.veeva.com ctv.veeva.com/study/a-study-to-evaluate-the-efficacy-and-safety-of-nexobrid-in-children-with-thermal-burns-compared-the

A Study to Evaluate the Efficacy and Safety of NexoBrid in ... This study will be a two-arms study intending to demonstrate superiority of NexoBrid treatment over SOC in children with thermal burns.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4283803/

Benchmarking Outcomes in the Critically Injured Burn Patient This study was designed to collect outcomes data from patients with significant burn injury (burns over 20% TBSA) requiring operative treatment.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06814717

A Safety, Tolerability and Pharmacokinetic Study of cP12 in ... 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 ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK430773/

Thermal Burns - StatPearls - NCBI Bookshelf - NIH Thermal burns cause both local injuries and, if severe (> 20% of body surface area), a systemic response. The local injuries can be roughly separated into ...

8. researchexperts.utmb.edu researchexperts.utmb.edu/en/publications/the-quality-of-life-after-major-thermal-injury-in-children-an-ana

The quality of life after major thermal injury in children The quality of life after major thermal injury in children: An analysis of 12 survivors with ≥80% total body, 70% third-degree burns · Overview · Fingerprint ...