A Safety, Tolerability and Pharmacokinetic Study of cP12 in Adults With Up To 5% Total Body Surface Area Burns
Purpose
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.
Condition
- Thermal Burns
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Safety study
- Primary Purpose
- Other
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Open-label |
Six adult male or female subjects will receive a single administration of 0.01mg/kg of cP12. |
|
Recruiting Locations
Washington D.C. 4140963, District of Columbia 4138106 20010
More Details
- Status
- Recruiting
- Sponsor
- Neomatrix Therapeutics, Inc.
Detailed 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. 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 in this study will be selected based on a burn classification description conducted prior to dosing with cP12. The selected burn must be deep partial-thickness and must not be a circumferential burn. In the absence of burn-specific, validated assessment tools, NeoMatrix has developed scales to characterize the burn and surrounding tissues for this trial. Burn assessments will include erythema, capillary refill, blisters, and edema/swelling. In this trial, the target burn and all other burns of each subject will be assessed. Eligible subjects will receive a single administration of 0.01 mg/kg cP12. Study drug will be administered over approximately 30 minutes by intravenous (IV) infusion with the subject in a supine position, and the infusion is to be initiated and completed within 2 to 12 hours after the burn has occurred. The subject is to remain in the supine position for 60 minutes from the start of study drug infusion (ie, during the 30-minute infusion and for 30 minutes after study drug infusion). 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.