NCT06814717 A Safety, Tolerability and Pharmacokinetic Study of cP12 in Adults With Up To 10% Total Body Surface Area Burns
| NCT ID | NCT06814717 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Neomatrix Therapeutics, Inc. |
| Condition | Thermal Burns |
| Study Type | INTERVENTIONAL |
| Enrollment | 6 participants |
| Start Date | 2025-05-12 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 6 participants in total. It began in 2025-05-12 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Jeffrey Shupp, MD
PRINCIPAL INVESTIGATOR
Medstar Health Research Institute
Frequently Asked Questions
Who can join the NCT06814717 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Thermal Burns. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06814717 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06814717 currently recruiting?
Yes, NCT06814717 is actively recruiting participants. Contact the research team at cara.m.delatore@medstar.net for enrollment information.
Where is the NCT06814717 trial being conducted?
This trial is being conducted at Washington D.C., United States.
Who is sponsoring the NCT06814717 clinical trial?
NCT06814717 is sponsored by Neomatrix Therapeutics, Inc.. The principal investigator is Jeffrey Shupp, MD at Medstar Health Research Institute. The trial plans to enroll 6 participants.