Recruiting
Phase 2

cP12

Sponsor:

Neomatrix Therapeutics, Inc.

Code:

NCT06814717

Conditions

Thermal Burns

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

cP12

Study Details

Brief 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. 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.

Conditions

Thermal Burns

Study ID

NCT06814717

Start date

May 12, 2025

Status verified date

Feb, 2026

Completion date

Nov 1, 2026

Anticipated

Primary completion date

Jul 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

6 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Open-label

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

Interventions

cP12

cP12 is a novel fibronectin derived, 14-mer peptide

Primary outcome measure

  • Incidence and severity of adverse events from dosing through follow-up [ Time Frame: Day 1, Day 3 and Day 14 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Cara Delatore

202-877-6402cara.m.delatore@medstar.net

Locations

Medstar Washington Hospital Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

More Information

Sponsor

Neomatrix Therapeutics, Inc.

Last update posted

Feb 18, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Neomatrix Therapeutics, Inc. on 2026-02-18.