A Safety, Tolerability and Pharmacokinetic Study of cP12 in Adults With Up To 10% Total Body Surface Area Burns

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.

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 Overview

• Status: Recruiting
• Conditions: Thermal Burns
• Intervention / Treatment: Drug: cP12

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 Type: Interventional
• Enrollment (Estimated): 6
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Cara Delatore; Phone Number: 202-877-6402; Email: cara.m.delatore@medstar.net

Study Locations

• United States
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Recruiting
      • Medstar Washington Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Open-label; Six adult male or female subjects will receive a single administration of 0.01mg/kg of cP12.	Drug: cP12; cP12 is a novel fibronectin derived, 14-mer peptide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of adverse events from dosing through follow-up	Clinical safety labs will be collected	Day 1, Day 3 and Day 14
Incidence and severity of adverse events from dosing through follow-up	Electrocardiograms will be performed	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	Baseline, Day 1 (2,5,15,30,60,90,120,240,360 minutes postdose), Day 3, Day 7 and Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigate pharmacokinetic profile	Blood samples will be analyzed for maximum plasma concentration (Cmax)	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	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)	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)	Predose, 2,5,15,30,60,120 and 240 minutes post dose

Collaborators and Investigators

• Sponsor: Neomatrix Therapeutics, Inc.
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Jeffrey Shupp, MD, Medstar Health Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: January 17, 2025
• First Submitted That Met QC Criteria: February 5, 2025
• First Posted (Actual): February 7, 2025

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 15, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: NMT-cP12-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No