cP12 for Thermal Burns

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

Trial Summary

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.

What safety data exists for cP12 or similar treatments in humans?

The available research does not provide specific safety data for cP12 or similar treatments in humans. However, general safety monitoring systems and databases, like the eAETS and STEP, are used to track adverse events and excipient safety, which can help ensure the safety of treatments in clinical trials. ^{1 2 3 4 5}

What is the purpose of this trial?

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 5% TBSA. Enrolled subjects must have at least 1% TBSA 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.

Research Team

Jeffrey Shupp, MD

Principal Investigator

Medstar Health Research Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. Netherlands pubmed.ncbi.nlm.nih.gov

The STEP (Safety and Toxicity of Excipients for Paediatrics) database: part 2 - the pilot version. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Applicability, reliability, sensitivity, and specificity of six Brighton Collaboration standardized case definitions for adverse events following immunization. [2008]

4. Germany 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. [2019]

5. Japan 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. [2019]