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
Neomatrix Therapeutics, Inc.
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.
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 10% TBSA. Enrolled subjects must have at least 1% superficial (epidermal), superficial partial-thickness, or deep partial-thickness burns. With the exception of the burns, subjects should be healthy and will be assessed to rule out smoke inhalation and other injuries. Vital signs prior to dosing must be stable and an electrocardiogram (ECG) must not show clinically significant abnormalities. The target burn used…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
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 abnorm…
Interventions
- DrugcP12
cP12 is a novel fibronectin derived, 14-mer peptide
Location
- Medstar Washington Hospital CenterWashington D.C., District of Columbia