Recruiting NCT06814717

A Safety, Tolerability and Pharmacokinetic Study of cP12 in Adults With Up To 10% Total Body Surface Area Burns

Phase II Interventional Thermal Burns

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: cP12.
Who it may be relevant to: Registry conditions: Thermal Burns. Basic parameters: 18 years — 65 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
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Official title

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

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 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.

Detailed description

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.

Interventions

Drug cP12
cP12 is a novel fibronectin derived, 14-mer peptide

Primary outcome measures

Incidence and severity of adverse events from dosing through follow-up [Time frame: Day 1, Day 3 and Day 14]
Incidence and severity of adverse events from dosing through follow-up [Time frame: Day 1 (Baseline and 1hour, 6 hours postdose), Day 3 and Day 14]
Incidence and severity of adverse events from dosing through follow-up [Time frame: Baseline, Day 1 (2,5,15,30,60,90,120,240,360 minutes postdose), Day 3, Day 7 and Day 14]

Secondary outcome measures (4)

Investigate pharmacokinetic profile [Time frame: Predose, 2,5,15,30,60,120 and 240 minutes post dose]
Investigate pharmacokinetic profile [Time frame: Predose, 2,5,15,30,60,120 and 240 minutes post dose]
Investigate pharmacokinetic profile [Time frame: Predose, 2,5,15,30,60,120 and 240 minutes post dose]
Investigate pharmacokinetic profile [Time frame: Predose, 2,5,15,30,60,120 and 240 minutes post dose]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Other

Study locations

United States · 1 center

Medstar Washington Hospital Center — Washington D.C.

Identifiers

NCT: NCT06814717 · NMT-cP12-201

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗