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

NCT06814717 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-02-18

No results posted yet for this study

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

Interventions

DRUG

cP12

cP12 is a novel fibronectin derived, 14-mer peptide

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Neomatrix Therapeutics, Inc.

    lead OTHER

Principal Investigators

  • Jeffrey Shupp, MD · Medstar Health Research Institute

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-12
Primary Completion
2026-07-01
Completion
2026-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06814717 on ClinicalTrials.gov