A Safety, Tolerability and Pharmacokinetic Study of cP12 in Adults With Up To 10% Total Body Surface Area Burns
Recruiting now · Phase 2
Conditions studied: Thermal Burns
In brief
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.
Key facts
- Study ID
- NCT06814717
- Run by
- Neomatrix Therapeutics, Inc.
- People needed
- 6
- Starts
- 2025-05-12
- Expected to finish
- 2026-11-01
- Last updated by the study team
- 2026-02-18
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States (enrolling)
Full record on ClinicalTrials.gov
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