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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
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.
This is a Standard of Care (SOC)- controlled study of approximately 44 patients divided into three sequential cohorts of 8, 12, and 24 patients. Within each sequential cohort, patients will be randomized to SOC only or to SOC plus Amicidin-β topical solution in a 1:3 ratio.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Snake River Research, PLLC
Idaho Falls, Idaho, United States
LifeBridge Health
Baltimore, Maryland, United States
The Ohio State University
Columbus, Ohio, United States
Start Date
February 2, 2026
Primary Completion Date
October 28, 2026
Completion Date
October 28, 2026
Last Updated
February 23, 2026
44
ESTIMATED participants
Amicidin-β topical solution - 15 mL
DRUG
Amicidin-β topical solution - 50 mL
DRUG
Standard of Care (SOC)
DRUG
Lead Sponsor
Macro Biologics, Inc.
Collaborators
NCT06319235
NCT06558240
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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