Actively Recruiting
A Safety, Tolerability and Pharmacokinetic Study of cP12 in Adults With Up To 10% Total Body Surface Area Burns
Led by Neomatrix Therapeutics, Inc. · Updated on 2026-02-18
6
Participants Needed
1
Research Sites
76 weeks
Total Duration
On this page
Sponsors
N
Neomatrix Therapeutics, Inc.
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Safety, Tolerability and Pharmacokinetic Study of cP12 in Adults With Up To 10% Total Body Surface Area Burns
Who Can Participate
Eligibility Criteria
You may qualify if you...
- BMI of at least 18 kg/m2 and body weight of 50 kg or more
- Thermal burns up to and including 10% total body surface area
- Burn must be superficial, superficial partial-thickness, or deep partial-thickness
- Able to receive cP12 infusion within 2 to 24 hours after burn
- Able to follow birth control requirements
You will not qualify if you...
- Burns on the head, face, or genital areas
- Smoke inhalation injury
- Active burn infection requiring systemic antimicrobial treatment
- Full-thickness burn in the target burn area
- Circumferential target burn
- Clinically significant lab abnormalities or medical history excluding participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
Research Team
C
Cara Delatore
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here