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

Conditions

• Thermal Burns

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• cP12 — DRUG
  cP12 is a novel fibronectin derived, 14-mer peptide

Study Details

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.

Key Dates

Start date

May 12, 2025

Status verified

Feb 2026

Primary completion

Jul 1, 2026

Completion

Nov 1, 2026

Study Design

Enrollment

6 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Arms

• Experimental: Open-label
  Six adult male or female subjects will receive a single administration of 0.01mg/kg of cP12.

Primary Outcome Measure

Incidence and severity of adverse events from dosing through follow-up [ Time Frame: Day 1, Day 3 and Day 14 ]

Central Contacts

• Cara Delatore
  202-877-6402
  [email protected]

Locations (1)

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