RecruitingPhase 1NCT07379684

A Study of Amicidin-β Topical Solution for Patients With Surgical or Traumatic Wound Infections

A Phase 1 Study to Assess Safety and Tolerability of Amicidin-β Topical Solution in Adult Patients Undergoing Interventional Management of a Surgical or Traumatic Wound Infection


Sponsor

Macro Biologics, Inc.

Enrollment

44 participants

Start Date

May 31, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this Phase 1 clinical trial is to learn about the safety profile of Amicidin-β topical solution applied directly into infected surgical or traumatic wounds during a surgical procedure. The main questions it aims to answer are: 1. Is Amicidin-β topical solution safe to test in larger clinical trials? 2. Is Amicidin-β topical solution absorbed into the bloodstream from local wound application? 3. Is Amicidin-β topical solution easy for the surgeon to use? Participants will receive either standard of care alone, or standard of care with intrawound Amicidin-β topical solution for the management of their wound infection. Researchers will compare these two groups (standard of care alone to standard of care with Amicidin-β topical solution) to see if there are any study drug-related adverse effects.


Eligibility

Min Age: 18 YearsMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Amicidin-β topical solution - 15 mL, a drug called Amicidin-β topical solution - 50 mL, and others for people with surgical wound infection and traumatic wound infection. The study is currently recruiting participants at 4 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAmicidin-β topical solution - 15 mL

Amicidin-β topical solution for local administration - 15 mL

DRUGAmicidin-β topical solution - 50 mL

Amicidin-β topical solution for local administration - 50 mL

DRUGStandard of Care (SOC)

Per institutional Standard Of Care


Locations(4)

Lundquist Institute

Torrance, California, United States

Snake River Research, PLLC

Idaho Falls, Idaho, United States

LifeBridge Health

Baltimore, Maryland, United States

The Ohio State University

Columbus, Ohio, United States

View Full Details on ClinicalTrials.gov

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NCT07379684


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