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

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.

NCT Number	NCT07379684
Lead Sponsor	Macro Biologics, Inc. Collaborators: Biomedical Advanced Research and Development Authority, Novo Nordisk Foundation, Global Antimicrobial Resistance Innovation Fund-(GAMRIF), US NIH Grant/Contract Award Number: HHS/BARDA OTA No. 75A50122C00028, Wellcome Trust 224842/Z/21/Z, Germany's Federal Ministry of Education and Research (BMBF) Agreement Dated 1/30/23, UK Secretary of State for Health and Social Care ("DHSC"), Agreement dated 02/28/2023
Conditions	Surgical Wound Infection, Traumatic Wound Infection
Enrollment	44 participants
Start Date	2026-08-31
Primary Completion	2027-02-28 (estimated)
Study Completion	2027-02-28 (estimated)
Updated on ClinicalTrials.gov	2026-07-22