A Safety, Tolerability and Pharmacokinetic Study of cP12 in Adults With Up To 5% Total Body Surface Area Burns

Launched by NEOMATRIX THERAPEUTICS, INC. · Feb 5, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called cP12 for adults who have experienced thermal burns covering up to 5% of their body. The study aims to see how safe the treatment is and how well it is tolerated by participants. To qualify for the trial, individuals must have at least 1% of their burn area classified as deep partial-thickness, which means the burn affects deeper layers of the skin. Eligible participants should weigh at least 50 kg and have a body mass index (BMI) between 18 and 40.

If you or someone you know qualifies, you would receive a single dose of cP12 and stay at the clinic for at least 6 hours for monitoring. During this time, your vital signs and pain levels will be checked, and blood and urine samples will be collected to ensure your safety. Follow-up visits will occur 3 and 7 days after the treatment, and there will be an end-of-study visit about two weeks later. It’s important to note that participants with burns on certain areas like the face or those with serious complications, such as infections, will not be eligible for the trial.

Gender

ALL

Eligibility criteria

• 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