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

NCT06814717 | Recruiting Phase 2 FDA Drug

• 1 other identifier: NMT-cP12-201
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thermal Burns

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (4)

• Investigate pharmacokinetic profile

  Predose, 2,5,15,30,60,120 and 240 minutes post dose

• Investigate pharmacokinetic profile

  Predose, 2,5,15,30,60,120 and 240 minutes post dose

• Investigate pharmacokinetic profile

  Predose, 2,5,15,30,60,120 and 240 minutes post dose

• Investigate pharmacokinetic profile

  Predose, 2,5,15,30,60,120 and 240 minutes post dose

Study Arms (1)

Open-label

EXPERIMENTAL

Six adult male or female subjects will receive a single administration of 0.01mg/kg of cP12.

Drug: cP12

Interventions

cP12 DRUG

cP12 is a novel fibronectin derived, 14-mer peptide

Open-label

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neomatrix Therapeutics, Inc.: lead
• United States Department of Defense: collaborator

Study Sites (1)

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Study Officials

• Jeffrey Shupp, MD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cara Delatore

CONTACT

202-877-6402; cara.m.delatore@medstar.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Safety study

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: February 7, 2025
• Study Start: May 12, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)