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A Study of Amicidin-β Topical Solution for Patients With Surgical or Traumatic Wound Infections
Sponsor: Macro Biologics, Inc.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
44
Start Date
2026-04-30
Completion Date
2027-02-28
Last Updated
2026-04-09
Healthy Volunteers
No
Interventions
Amicidin-β topical solution - 15 mL
Amicidin-β topical solution for local administration - 15 mL
Amicidin-β topical solution - 50 mL
Amicidin-β topical solution for local administration - 50 mL
Standard 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