Evaluating cP12 for treating thermal burns in adults
A Phase 2a, Open-Label Study of the Safety, Tolerability, and Pharmacokinetics of a Single Dose of cP12 in Otherwise Healthy Adults With Up To and Including 10% Total Body Surface Area Thermal Burns
PHASE2 · Neomatrix Therapeutics, Inc. · NCT06814717
This study is testing a new treatment called cP12 to see if it helps adults with thermal burns heal better and safely after their injuries.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 6 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Neomatrix Therapeutics, Inc. (other) |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Trial ID | NCT06814717 on ClinicalTrials.gov |
What this trial studies
This Phase 2a, open-label study assesses the safety, tolerability, and pharmacokinetics of a single dose of cP12 in adults with thermal burns covering up to 5% of their total body surface area. Participants must have at least 1% deep partial-thickness burns and will receive the treatment within 2 to 12 hours post-burn. The study involves monitoring vital signs, ECGs, and conducting burn assessments at various time points, including follow-up visits at 3, 7, and 14 days after dosing. The aim is to ensure participant safety while evaluating the drug's effects on burn recovery.
Who should consider this trial
Good fit: Ideal candidates are adults with thermal burns of up to 5% TBSA, specifically those with at least 1% deep partial-thickness burns.
Not a fit: Patients with burns to the head, face, or genitalia, or those with full-thickness or circumferential burns will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve recovery outcomes for patients with thermal burns.
How similar studies have performed: While this approach is novel, similar studies have explored treatments for burns, but the specific use of cP12 is untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Washington D.C., District of Columbia
- Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States (RECRUITING)
Study contacts
- Principal investigator: Jeffrey Shupp, MD — Medstar Health Research Institute
- Study coordinator: Cara Delatore
- Email: cara.m.delatore@medstar.net
- Phone: 202-877-6402
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Thermal Burns