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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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 in this study will be selected based on a burn classification description conducted prior to dosing with cP12. The selected burn must be superficial (epidermal), superficial partial-thickness, or 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 24 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-label | Experimental | Six adult male or female subjects will receive a single administration of 0.01mg/kg of cP12. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cP12 | Drug | cP12 is a novel fibronectin derived, 14-mer peptide |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events from dosing through follow-up | Clinical safety labs will be collected | Day 1, Day 3 and Day 14 |
| Incidence and severity of adverse events from dosing through follow-up | Electrocardiograms will be performed | Day 1 (Baseline and 1hour, 6 hours postdose), Day 3 and Day 14 |
| Incidence and severity of adverse events from dosing through follow-up | Vital signs will be collected | Baseline, Day 1 (2,5,15,30,60,90,120,240,360 minutes postdose), Day 3, Day 7 and Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Investigate pharmacokinetic profile | Blood samples will be analyzed for maximum plasma concentration (Cmax) | Predose, 2,5,15,30,60,120 and 240 minutes post dose |
| Investigate pharmacokinetic profile |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cara Delatore | Contact | 202-877-6402 | cara.m.delatore@medstar.net |
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Shupp, MD | Medstar Health Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medstar Washington Hospital Center | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
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Safety study
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Blood samples will be analyzed for area under the plasma concentration (AUC) versus time curve
| Predose, 2,5,15,30,60,120 and 240 minutes post dose |
| Investigate pharmacokinetic profile | Blood samples will be analyzed for half-life (t1/2) | Predose, 2,5,15,30,60,120 and 240 minutes post dose |
| Investigate pharmacokinetic profile | Blood samples will be analyzed for time to reach maximum plasma concentration (Tmax) | Predose, 2,5,15,30,60,120 and 240 minutes post dose |