A Safety, Tolerability and Pharmacokinetic Study of cP12 in Adults With Up To 5% Total Body Surface Area Burns

Description

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 5% TBSA. Enrolled subjects must have at least 1% TBSA 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

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Study Overview

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Study Details

Study overview

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 5% TBSA. Enrolled subjects must have at least 1% TBSA 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.

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 5% Total Body Surface Area Thermal Burns

A Safety, Tolerability and Pharmacokinetic Study of cP12 in Adults With Up To 5% Total Body Surface Area Burns

Condition
Thermal Burns
Intervention / Treatment

-

Contacts and Locations

Washington

Medstar Washington Hospital Center, Washington, District of Columbia, United States, 20010

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * BMI between 18 kg/m2 (inclusive) and body weight \>/=50kg
  • * TBSA thermal burns up to and including 5%, with at least 1% deep partial- thickness burn
  • * Able to be infused with cP12 within 2 to 12 hours post burn
  • * Able to follow birth control requirements
  • * 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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Neomatrix Therapeutics, Inc.,

Jeffrey Shupp, MD, PRINCIPAL_INVESTIGATOR, Medstar Health Research Institute

Study Record Dates

2026-11-01