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RECRUITING
NCT07379684
PHASE1

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

Sponsor: Macro Biologics, Inc.

View on ClinicalTrials.gov

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

DRUG

Amicidin-β topical solution - 15 mL

Amicidin-β topical solution for local administration - 15 mL

DRUG

Amicidin-β topical solution - 50 mL

Amicidin-β topical solution for local administration - 50 mL

DRUG

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